consultants(1).pdf

8/17/2019 consultants(1).pdf

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2014 List of Consultants (see Disclaimer)

Company Name / Address Contact InformationSummary of Services (see Notes)

Product Areas: Services: Countries:

ACERNA Inc.

19 Bryant Road

Markham, ON

L3P 5Y7

Paul J. Larocque, President

Tel: 905-472-5747

[email protected]

www.Acerna.ca

Pharmaceuticals

Biologics

Medical Devices

Over-the-counter Products

Good Manufacturing Practices,especially for sterile, aseptic, andbiological processes

Compliance resolution, includingHealth Canada and FDA WarningLetters

Medical Device Quality Systems

Regulatory Affairs

Canada

United States

Europe

Adiantum Consultant-e

Boucherville

Québec

Julie Naud

Tel: 450-641-2696

Fax: 450-655-0204

[email protected]

www.adiantumconsultant-e.com

Food

Cosmetics

OTC pharmaceuticals

Natural Health Products

Dietary supplements

Adiantum consultant-e: for yourscientific and regulatory needs

NPN, OTC DIN, Site licensing,SOPs, Supplement Facts table,Nutritional Facts table, Sitelicensing, label text revision, etc.

Canada

United States

Amei-Can RegulatoryExperts

7256 Airport Road

Suite 111Mississauga, Ontario

L4T 3V1

[email protected]

www.americanregexperts.com

Pharmaceuticals

Medical Devices NaturalHealth Products

Ameri-Can Regulatory Expertshelps importers/manufacturers/

distributors for Product

Registrations Establishment/Site Licensing,

Liaison with Health Canada

SOP Development

GMP Compliance, release/rejectprograms and facilitate HealthCanada audits and registeredtrademark.

REGULATORY AFFAIRS MADEEASY

Canada,

United States Australia

http://www.acerna.ca/http://www.acerna.ca/mailto:[email protected]://www.adiantumconsultant-e.com/mailto:[email protected]://www.americanregexperts.com/http://www.americanregexperts.com/http://www.americanregexperts.com/mailto:[email protected]://www.adiantumconsultant-e.com/mailto:[email protected]://www.acerna.ca/


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AmoSey Inc.

Suite 11

39-173 Advance Boulevard

Brampton, ON

L6T 4Z7

Canada

Sharavathi Ponnuswamy

Tel: 647-624-9628

Fax:289-597-1631

[email protected]

www.amoseyinc.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



A to Z of Pharmaceutical Industry

Establishment/Site Licensing,

Regulatory Submissions,

Compliance, GXP, pre-approvalInspections,

QA, Validation, Clinical Research,

Pharmacovigilance, Formulary

Advertising

eCTD service

Translation Services for > 30languages

Canada

United States

Europe

Asia

India

Australia

AxSource Consulting Inc.

336 Bronte Street South

Suite 224-225

Milton, ON

L9T 7W6

Ms. Navneet Sekhon, President

Tel: 905-854-6059

Cell: 416-452-0100

[email protected]

www.axsource.ca

Drugs/Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



GMP,GLP,GCP & ISO

Regulatory Affairs, QA/QC,Compliance, Clinical, Engineering,Validations incl. Software (CSV)

Pre-inspection, Compliance &consultant audits

On-site & Virtual RAQA services EH&S services

Clinical Laboratory Consulting &Certification services

Litigation support

Canada

United States

Europe

Asia

Australia

http://www.amoseyinc.com/http://www.amoseyinc.com/mailto:[email protected]:[email protected]://www.axsource.ca/http://www.axsource.ca/http://www.axsource.ca/mailto:[email protected]://www.amoseyinc.com/


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BNA Consultant Group

301, Dorval Av.

Suite 120

Dorval, Quebec

H9S 2H6

Rachid Akhiate

Tel: 514-774-1046

Fax: 514-631-3868

[email protected]

www.GBNAC.com



Cosmetics

Veterinary Drugs Medical Devices

Food

Regulation of natural healthproducts

Health supplements

Foods and pharmaceuticals

Assists natural health product andpharmaceutical companies tofacilitate and guide them through

the regulation procedures

Canada

Canadexlabs

725 Place Fortier #707

Montreal, Quebec

H4L 5B9

Mr. Fayez Chehab

Tel: 514-978-4466

Fax: 514-747-7550

[email protected]

www.canadexlabs.com

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics



Health Canada drug submissions:(NDS) (SNDS)(ANDS) (NC) (DIN)

Health Canada Natural Healthproducts submissions: (NPN)

Quality Control & Qualityassurance

GMP Compliance & Productregistration

Canada

United States

Europe

Gulf ArabicStates (GCCcountries)

Certus PV Services11-1155 North Service RoadWest

Oakville, ON L6M 3E3

Canada

Rita Cassola

Tel: 289-291-3942

[email protected]

www.certuspv.com

Pharmaceuticals Biologics

Radiopharmaceuticals



Cosmetics

Veterinary Drugs

Certus PV provides expert pre-approval and post-marketpharmacovigilance as well asmedical information services

CanadaUnited States

mailto:[email protected]:[email protected]://www.gbnac.com/http://www.gbnac.com/mailto:[email protected]:[email protected]://www.canadexlabs.com/http://www.canadexlabs.com/mailto:[email protected]://www.certuspv.com/http://www.certuspv.com/mailto:[email protected]://www.canadexlabs.com/mailto:[email protected]://www.gbnac.com/mailto:[email protected]


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Chestnut Solutions Inc.

86 Otter Cres.

Toronto, ON

M5N 2W8

Helen Teichman

Tel: 416-783-2945

[email protected]

www.chestnutsolutions.com

Pharmaceuticals eCTD and NeeS publishing andmanagement.

Implementation and best practicesfor electronic submissions anddocument management

Templates, training, SOPpreparation

Canada

United States

Europe

Coley Consulting Inc.991 Peggoty Circle

Oshawa, Ontario

L1K 2G5

Alan Coley

416-786-4916

905-436-2808

[email protected]

www.alancoleyconsulting.com

Pharmaceuticals BiologicsVeterinary Drugs

Medical Devices


Regulatory Submissions Quality Systems Development and

Implementation

Good Manufacturing Practices

GAP Analysis Training

CanadaUnited StatesEurope

Consultations Madgo

6-1297,rue Jasmin

Laval, Quebec

H7W 3V9

Madeleine Gomez

Tel: 450-973-9553

[email protected]

www.consultationsmadgo.com

Pharmaceuticals

Medical Devices Quality Management and Assurance

Regulatory Affairs

For additional information visit ourwebsite

Canada

Consultations NathalieLebel Inc.

1768 chemin St-Charles,Local 101Terrebonne, QuebecJ6W 0B7

Nathalie Lebel

Tel: 450-416-0922

Fax: 450-416-4922

[email protected]

www.lebelpharma.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Regulatory Affairs

Quality Control and QualityLicensing

Client representation during HealthCanada Inspection and negotiationwith Health Canada

Training and Education

Canada

mailto:[email protected]:[email protected]://www.chestnutsolutions.com/http://www.chestnutsolutions.com/mailto:[email protected]://www.alancoleyconsulting.com/mailto:[email protected]:[email protected]://www.consultationsmadgo.com/http://www.consultationsmadgo.com/mailto:[email protected]:[email protected]://www.lebelpharma.com/http://www.lebelpharma.com/http://www.lebelpharma.com/mailto:[email protected]://www.consultationsmadgo.com/mailto:[email protected]://www.alancoleyconsulting.com/mailto:[email protected]://www.chestnutsolutions.com/mailto:[email protected]


5/21

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dicentra

27 Prince Arthur Avenue

Toronto, ON

M5R 1B2

Peter Wojewnik

Tel: 416-361-3400

Fax: 416-361-3304

[email protected]

www.dicentra.com

Pharmaceuticals

Medical Devices

Cosmetics


dicentra provides sought-afterregulatory and scientific guidanceon health-related products sold inNorth American marketplaces.

Canada

United States

DSA Consultants

1660 North Service Road E.

Units 106 & 107

Oakville, ON, L6H 7G3

Canada

Mark Moody

Tel: 905-827-0057 ext.229

Fax: 905-827-0060

[email protected]

www.dsaconsultants.com

PharmaceuticalsBiologics

Veterinary Drugs

Medical Devices

Cosmetics



MMPR

Regulatory Affairs, Quality Controland Quality Assurance

Product Registrations,Establishment/Site Licensing,Liaison with Health Canada, SOPDevelopment, GMP Compliance,

Audits and more

Pharmacovigilance

Canada

Eric Leblanc

36 Bellefeuille

MercierQuébec, J6R 2P2

Canada

Eric Leblanc

Tel:514-929-4891E-mail: [email protected]

Pharmaceutiques

Biologiques CMC regulatory affairs compliance

IND and CTA in eCTD format

Technical writing Technology transfer

Analytical procedure developmentand validation

Quality assurance

GMP compliance audit

Canada

United States

mailto:[email protected]:[email protected]://www.dicentra.com/http://www.dicentra.com/mailto:[email protected]:[email protected]://www.dsaconsultants.com/http://www.dsaconsultants.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.dsaconsultants.com/mailto:[email protected]://www.dicentra.com/mailto:[email protected]


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FasTrack Consulting

12 Forestgrove Drive

Ottawa, ON K2S 1V2

Dr. Kathy A. Zito

Tel: 613-286-2089

[email protected]

www.fastrackconsulting.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Medical MarijuanaPlant-basedPharmaceuticals

Canada

United States

Europe

Grieb Consulting

(VG Solutions)

1060 de Canna

Laval, QC

H7X 3W4

Victoria Grieb

Tel: 450-314-3545, 514-651-0465

Fax: 450-314-3585

[email protected]

Pharmaceuticals

Medical Devices

Cosmetics



Food

Regulatory affairs for cosmetics,OTC drugs, NHPs and food

DIN, NPN applications, Medicaldevice licenses

Liaison – Health Canada

Regulatory training

GMP, QA/QC

Packaging review Environmental compliances

Certificates of Free Sale (ITCs)

English or French, includingtranslations

Canada

mailto:[email protected]://www.fastrackconsulting.com/http://www.fastrackconsulting.com/mailto:[email protected]:[email protected]:[email protected]://www.fastrackconsulting.com/mailto:[email protected]


7/21

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Innovia-Biopharma

141 rue Ovila

Rosemere, Quebec

J7A 4L2

Gilles Chaumillon

Tel: 514-918-5677

Fax: 450-965-0105

www.innovia-biopharma.com

[email protected]

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics


Establishment/Site Licensing,

Regulatory Submissions (drug,NPN, device),

Regulatory/Quality ComplianceQuality system implementation(ISO 13485, HACCP)

Internal & External Audits

Canada

International Food FocusLtd.

211 Carlton Street

Toronto, ON

M5A 2K9

Carol T. Culhane

Tel: 416-924-3266

Fax: 416-924-2726

[email protected]

www.foodfocus.on.ca

Food Ingredients

Novel Foods

Novel Fibres

Processed Food

Infant Formula


Animal Feed Supplements

Pre-commercialization and pre-market notification: assimilation ofscientific dossiers for regulatorreview

Post-commercialization labelcreation (including Frenchtranslation) or audit

Regulatory and market impactstudies

Learning & Development – seminars and workshops

Canada

USA

EU

Intertek Scientific &Regulatory Consultancy

2233 Argentia Rd.,

Suite 308

Mississauga, ON

L5N 2X7

Anna Metcalfe

Tel: 905-542-2900

Fax: 905-542-1011

[email protected]

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Intertek's experts provideassistance at all stages of productdevelopment to clients in thepharmaceutical, biotechnology,and medical device fields

Canada

United StatesEurope

Asia

Africa

Australia

Latin America

http://www.innovia-biopharma.com/mailto:[email protected]:[email protected]:[email protected]://www.foddfocus.on.ca/http://www.foddfocus.on.ca/mailto:[email protected]:[email protected]:[email protected]://www.foddfocus.on.ca/mailto:[email protected]:[email protected]://www.innovia-biopharma.com/


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Intrinsik Health SciencesInc.

6605 Hurontario Street

Suite 500

Mississauga, Ontario

L5T 0A3

Katharine Manson

Tel: 905-364-7800 ext. 209

Fax: 905-364-7816

[email protected]

www.intrinsik.com

Pharmaceuticals Biologics

Veterinary Drugs MedicalDevices Cosmetics



Intrinsik Health Sciences is aspecialized group of regulatory andtoxicology professionals withbackgrounds from large andemerging pharmaceutical,biotechnology companies, andconsulting firms. Cumulatively, ourteam provides your company withyears of relevant experience tohelp with all stages of drugdevelopment

Canada

United StatesEurope

Asia

Australia

JC QA Consultants Inc.

10 Parkview Place

Brampton, ON L6W 2G1

Canada

John Collins

Tel: 905-450-5798

Cell: 647-985-8764

[email protected]

www.jcconsultants.ca

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics

Non-prescription drugs


Medical Marijuana

Quality & Compliance Experts forPharmaceutical, Natural Healthand Medical Marijuana Products.

Expertise in Audits/Inspections(Performing/Hosting), APRs/QPRs,Batch Release/Certification,Computer Validation, Clinical QA,

Deviation & CAPA Management,Medical Marijuana, QA

Agreements, Risk Assessments(Site/Vendor/Product),Site QualityManagement, StabilityReview/Protocols, TemperatureMonitoring/Cold Chain Packaging,Training, Validation


mailto:[email protected]://www.intrinsik.com/mailto:[email protected]://www.jcconsultants.ca/http://www.jcconsultants.ca/mailto:[email protected]://www.intrinsik.com/mailto:[email protected]


9/21

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K. Friedman Consulting

537 Bedford Park Ave.

Toronto, ON

M5M 1K4

Karen Friedman

Tel: 416-783-9394

Fax: 416-783-3114

[email protected]

www.kfriedmanconsulting.com

Pharmaceuticals


Preparation of natural healthproduct applications and sitelicense applications

Preparation of new andsupplemental new drugsubmissions, clinical trialapplications, notifiable changes

Preparation of DIN applications Cosmetic regulatory affairs

QA

Drug Establishment Licenses

MMPR Consulting for LicensedProducers

Canada

Lockhart RegulatoryServices Inc.

1860 Appleby Line,

Suite 348

Burlington, OntarioL7L 7H7

Marilyn Lockhart

Tel: 905 635-2855

[email protected]

Pharmaceuticals

Medical Devices

Over-the-CounterProducts


Experienced

Results-Oriented

Recognized

Regulatory and Quality

Canada

United States

mailto:[email protected]:[email protected]://www.kfriedmanconsulting.com/http://www.kfriedmanconsulting.com/mailto:[email protected]:[email protected]:[email protected]://www.kfriedmanconsulting.com/mailto:[email protected]


10/21

10




MarcM Consulting Canada

172 Mausser Avenue

Kitchener, ON

N2M 3K7

Marcela Saad

Tel: 519-579-0821

Fax: 519-579-0821

[email protected]

www.marcmconsulting.ca

http://ca.linkedin.com/pub/marcela-saad/7/30b/bb3

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Regulatory strategy, productregistrations & post-marketchanges

Clinical trial & establishmentlicense applications

Quality System & GMP/GCP/ISOcompliance

Extensive expertise in the Americas in English, Portuguese &Spanish

Canada

United States

Latin America

Europe

McCarthy ConsultantServices, Inc.

1151 Gorham Street

Unit 8

Newmarket, ON

L3Y 8Y1

Dorothy Partridge

Tel: 905-836-0033

Fax: 905-836-0006

[email protected]

www.mccarthyconsultant.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Foods

MCSI is trusted and valued by thepharmaceutical, biotechnology,medical device, food, naturalhealth products and cosmeticindustries for its efficient, timely,and effective regulatory work.

Canada

United States

Europe

MCS Associates Inc.

1060 Tapscott Road

Toronto, Ontario

M1X 1E7

Tel: 416-286-6062 Ext. 227

Fax: 416-286-0146

[email protected]

www.mcs-associates.com

mailto:[email protected]:[email protected]:[email protected]://www.marcmconsulting.ca/http://www.marcmconsulting.ca/http://ca.linkedin.com/pub/marcela-saad/7/30b/bb3http://ca.linkedin.com/pub/marcela-saad/7/30b/bb3http://ca.linkedin.com/pub/marcela-saad/7/30b/bb3mailto:[email protected]:[email protected]://www.mccarthyconsultant.com/http://www.mccarthyconsultant.com/mailto:[email protected]:[email protected]://www.mcs-associates.com/http://www.mcs-associates.com/mailto:[email protected]://www.mccarthyconsultant.com/mailto:[email protected]://ca.linkedin.com/pub/marcela-saad/7/30b/bb3http://ca.linkedin.com/pub/marcela-saad/7/30b/bb3http://www.marcmconsulting.ca/mailto:[email protected]:[email protected]


11/21

11




Natural Products ConsultingCorporation

29 East Wilmont Street

Richmond Hill, Ontario

L4B 1A3

Lionel Pasen

Tel: 905-763-9999

Fax:905-784-1110

[email protected]

www.npc-corp.ca


Natural Health Products Since 1959:

NHPs,OTCs,cosmetics,dietarysupplements,foods,SiteLicences,claim substantiation.Notarized International TradeCertificates. Computerizedapplications (over 6000completed), efficient and costeffective

Canada

United States

Latin America

Normand RobichaudServices conseils inc.

4025 chemin Sainte-Foy

Quebec, Quebec

G1Y 1T7

Normand Robichaud

Tel: 418-650-5628

[email protected]

www.normandrobichaud.com

Pharmaceuticals

Medical Devices

Cosmetics



Services conseils en BonnesPratiques de Fabrication (BPF)

Systèmes Qualité

Audits Qualité

Conformité pour l’industriepharmaceutique, cosmétique, desbiotechnologies et des produits desanté naturels

Canada

United States

Europe

Nutrasource Diagnostics

Inc.Suite 203

120 Research Lane

University of Guelph

Research Park,

Guleph, ON

N1G 0B4

Krista Coventry, M.Sc.

Tel: 519-341-3363

Fax: 519-341-3368

[email protected]

www.nutrasource.ca

Pharmaceuticals

Natural Health ProductsFunctional Food &Beverages

Foods

Medical Devices

Cosmetics

Regulatory Affairs Project

Management

Regulatory Applications(Pharmaceuticals/NHPs/ MedicalDevices/Foods)

Clinical Trial Design/Implementation/

Monitoring/Data Management

Facility Compliance(Auditing/GMPs/SOPs)

Canada

United States

mailto:[email protected]:[email protected]://www.npc-corp.ca/http://www.npc-corp.ca/mailto:[email protected]:[email protected]://www.normandrobichaud.com/http://www.normandrobichaud.com/mailto:[email protected]:[email protected]://www.nucro-technics.com/http://www.nucro-technics.com/http://www.nucro-technics.com/mailto:[email protected]://www.normandrobichaud.com/mailto:[email protected]://www.npc-corp.ca/mailto:[email protected]


12/21

12




Optum

(formerly CanReg Inc.)

4 Innovation Drive

Dundas, ON

L9H 7P3

Darrell Ethell

Tel: 905-689-3980

Fax: 905-689-1465

[email protected]

www.optuminsight.com/srs

Pharmaceuticals

Biologics

Medical Devices

Cosmetics



Regulatory Affairs, CMC and QAservices

eCTD & NeeS (preparation,management and hosting)

Pharmacovigilance/MedicalInformation

CTAs/Canadian agent services

Canadian Importer of Record Quality systems (GMP, ISO13485)

Environmental regulatory

Canada

United States

Europe

Asia

Africa

Australia

Latin America

Pharmalink Consulting

51 John F Kennedy Pkwy,4th Fl

Short Hills, NJ

07078

USA

Ghali Asad

Tel: 973-921-5247

[email protected]

www.pharmalinkconsulting.com

Pharmaceuticals

Biologics

Medical DevicesCosmetics


Whatever your needs, FDA

regulations or working with globalregulatory affairs agencies we canresource any healthcare regulatoryaffairs project, regardless of sizeand timescale.

Our expertise has been developed

and crafted by working for manyyears in the continually evolvinghealthcare arena.


Asia

Africa Australia

Latin America

mailto:[email protected]:[email protected]://www.optuminsight.com/srshttp://www.optuminsight.com/srsmailto:[email protected]://www.pharmalinkconsulting.com/http://www.pharmalinkconsulting.com/mailto:[email protected]://www.optuminsight.com/srsmailto:[email protected]


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PharmEng Technology

23 Lesmill Road,

Suite 410

Toronto, ON M3B 3P6

Canada

Ben Lee

Tel: 416-385-3922 ext. 103Fax: 416-385-3912

[email protected]

www.pharmeng.com

www.medmarijuanaexperts.com

Pharmaceuticals

Biologics




MMPR

Commissioning & Qualification

Validation

Regulatory Affairs

Quality Control

Engineering

Project Management

Serialization

Tech Transfer

Information Technology

SOPS

Audits

MMPR Consulting

Training

Canada

United StatesEurope

Asia

Africa

Australia

Latin America

Proficio Scientific Affairs Inc.

3700 St-Patrick

Suite 240

Montreal, Quebec

H4E 1A2

Simon Alexander

Tel: 514-296-0125

Fax: 514-933-7208

[email protected]

www.proficioconsult.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices



Expert Regulatory Support for:

Clinical Trials (devices, drugs,biologics)

Product Registration; eCTD

Health Authority Meetings &Negotiations

Post-market & Life-cyclemanagement

20 years regulatory affairs &development experience

Canada

mailto:[email protected]://www.pharmeng.com/http://www.medmarijuanaexperts.com/http://www.medmarijuanaexperts.com/mailto:[email protected]:[email protected]://www.proficioconsult.com/http://www.proficioconsult.com/http://www.proficioconsult.com/mailto:[email protected]://www.medmarijuanaexperts.com/http://www.pharmeng.com/mailto:[email protected]


14/21

14




PRTox Consulting Inc.

922 Pezer Cres

Saskatoon

Saskatchewan, S7S 1J8

Daniel Bechtel

Tel: 306-652-6271

[email protected]

prtox.ca

PharmaceuticalsVeterinary DrugsCosmetics



Pest Control Products

Consumer Chemicals and

Containers

Regulatory guidance, dossierpreparation and submission.

Toxicology protocol developmentand management.

Scientific guidance for analytical,environmental and human healthregulatory documentation.

Canada

Quality & ComplianceServices Inc.

9-6975 Meadowvale TownCentre, Suite 410

Mississauga, ON

L5N 2V7

Stephen Semple

Tel: 905-363-1182, ext.210

Fax: 905-542-7981

[email protected]

www.qualityandcompliance.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Q &C® ‘s full-time consultantsprovide complete regulatory,quality control and complianceservices for the pharmaceutical,natural health product, cosmeticand medical device industries andtheir suppliers.

Canada

United States

Europe

Asia

Australia

Latin America

RaQa Consulting Inc.

4 Robert Speck Parkway

15th FloorMississauga, ON

L4Z 1S1

Sandra Ireland

Tel/Fax: 1-866-697-7272

[email protected]

www.raqaconsulting.ca

Medical Devices

Cosmetics

DrugsNatural Health Products

Foods

Complete Business Solutions andProject Management for

manufacturing/importing anddistributing drugs, medical devices,cosmetics and NHP's.

Canada

United States

mailto:[email protected]:[email protected]:[email protected]://www.qualityandcompliance.com/http://www.qualityandcompliance.com/mailto:[email protected]://www.raqaconsulting.ca/http://www.raqaconsulting.ca/mailto:[email protected]://www.qualityandcompliance.com/mailto:[email protected]:[email protected]


15/21

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Redstone Health Group Inc.

2125 Galena Cres.

Oakville, ON L6H 4A9

Canada

Karen Feltmate

Tel: 905-842-4230

Fax: 905-338-8970

[email protected]

www.redstonehealthgroup.com

Pharmaceuticals We provide strategic andoperational regulatory support thatalign and enhance your greaterbusiness strategy.

Canada

Reg-Affairs & QualiPractixisInc.

370 Stone Road, Suite 20

Guelph, ON N1G 4V9

Canada

Olufemi Adeoye

Tel: 226-780-0216

Fax: 226-780-0216

[email protected]

www.reg-affairsqp.com

Pharmaceuticals




We provide Regulatory and Qualitycompliance services that cover theentire life-cycle of the followinghealthcare products:

- Prescription & OTC DrugProducts

- Medical Devices- Natural Health Products (only

in Canada)

- Cosmetic Products- Low Risk Veterinary Health

Products (LRVHP)


Asia

Africa Australia

Latin America

mailto:[email protected]:[email protected]://www.redstonehealthgroup.com/mailto:[email protected]://www.reg-affairsqp.com/http://www.reg-affairsqp.com/mailto:[email protected]://www.redstonehealthgroup.com/mailto:[email protected]:[email protected]


16/21

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Regxia Inc.

5-133 The West Mall

Toronto, ON

M9C 1C2

Cameron McGregor

Tel: 416-620-5236

Fax: 416-620-0261

[email protected]

www.regxia.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices


Regulatory Affairs

Dossier Compilation &Management

eCTD (preparation, managementand publishing)

CMC

Clinical & Quality services

Clinical Monitoring & Management Pharmacovigilance

SOPs & Reporting

CTAs, IND, NDS, ANDS, etc.

Canada

United States

Europe

Regulatory Solutions Inc.

5 Strawberry Hill Court

Caledon, ON

L7E 1R9

Jane P. Costaris

Tel: 905-857-3132

Fax: 905-857-3816

[email protected]

www.regulatorysolutions.ca

Pharmaceuticals

Medical Devices


RSI specializes in timely,innovative and strategic Regulatory

Affairs approvals from HealthCanada ((S)ANDS, (S)NDS,DIN(A), DEL, Post-NOC)

Provincial Formulary Submissions

eCTD Submissions Pharmacovigilance

Canada

mailto:[email protected]:[email protected]://www.regxia.com/http://www.regxia.com/mailto:[email protected]:[email protected]://www.regulatorysolutions.ca/http://www.regulatorysolutions.ca/http://www.regulatorysolutions.ca/mailto:[email protected]://www.regxia.com/mailto:[email protected]


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Robin Loconte

150 Forbes Terrace

Milton, ON

L9T 4V1

Robin Loconte

Tel: 905-805-1349

[email protected]

Pharmaceuticals

Biologics

Specializing in the developmentand execution of regulatorystrategies to support Canadianproduct approvals:

Canadian Health Authoritysubmissions

Regulatory risk assessment

Regulatory strategy development Health Authority meetings

Expert Advisory Boards

Document writing

Presentation development

Canada

Source Nutraceutical, Inc.

1 – 1249 Clarence Avenue

Winnipeg, Manitoba

R3T 1T4

Bernie Desgagnes

Tel: 204-254-2234

Fax: 204-254-7817

[email protected] www.sourcenutra.ca

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics



Your “one-stop-solution” forregulatory compliance, graphicdesign, bilingual labeling andimportation and fulfillment servicesfor foods, natural health products,cosmetics, medical devices andpharmaceutical products

Canada

United States

mailto:[email protected]:[email protected]://www.sourcenutra.ca/http://www.sourcenutra.ca/http://www.sourcenutra.ca/mailto:[email protected]


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SPEK RegulatoryConsultants

4080 Farnsworth Cres.

Mississauga, ON

L5L 3Z3

Sunita Phull / Ella Dratewka-Kos

Tel: 647-234-4930

416-560-6637

Fax: 416-223-9875

[email protected]

Pharmaceuticals

Natural Health Products 40+ years of combined experience

- Regulatory advice and strategy- Post-marketing changes- DIN submissions- NHP submissions (PLAs)- Establishment Licence

submissions- CTAs and Amendments- Pre-CTA meetings and GCP

inspection support- SOP development for

regulatory processes.

Canada

SpringBoard Solutions Inc.

1332 Nocturne Court

Mississauga, ON

L5H 2L8

Sheila Garven

Tel: 416-619-9025

[email protected]

www.springboardsolutions.ca

Pharmaceuticals

Biologics Regulatory support in the filing and

approval of drug submissions

Development of position papers onregulatory policy issues

Provide affidavits and testimony inpatent cases

Canada

mailto:[email protected]:[email protected]://www.springboardsolutions.ca/http://www.springboardsolutions.ca/http://www.springboardsolutions.ca/mailto:[email protected]


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Stan North Consultation

166 Promenade Sheraton

Montreal-Ouest

Quebec, H4X 1N4

Stan North, M.Sc.

Tel: 514-577-5913

[email protected]

www.StanNorthConsultation.com

Pharmaceuticals

Biologics

Medical Devices



Cosmetics

Regulatory consulting for thepharma, medical device andbiotech sectors

Clinical and CMC submissions

CTAs

Project management

Product monographs and labeling

Regulatory guidance and strategy We offer quality service, flexibility

and customer-focus with over 20years of industry experience

Canada

SYLLA CONSEILS INC.

2149 Lincourt

Longueuil, Quebec

J4N 1N8

Sylvie Lachance

Tel: 450-332-0928

Cell:514-823-0928

Fax:450-332-0928

[email protected] www.syllaconseils.com

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics



Regulatory Affairs

DIN,NPN applications & Medicaldevice licences

Establishment/Site Licensing

QC/QA implementation & follow-up

GMP’s, GLP’s,SOP’s training

Internal & External Audits Liaison with Health Canada & FDA

during inspection

Packaging review

Canada

United States

Europe

Therapeutic Products Inc.

1269 Centre Rd.Hamilton, ONL8N 2Z7

Anne Tomalin

Tel: 905-690-4343Fax: 905-690-4242

[email protected]

PharmaceuticalsBiologicsOver-the-counter ProductsNatural Health Products

Regulatory consulting

Pharmacovigilance services

CanadaUnited States

mailto:[email protected]:[email protected]://www.stannorthconsultation.com/http://www.stannorthconsultation.com/mailto:[email protected]:[email protected]://www.syllaconseils.com/http://www.syllaconseils.com/mailto:[email protected]:[email protected]://www.syllaconseils.com/mailto:[email protected]://www.stannorthconsultation.com/mailto:[email protected]


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Trillium Technologies GroupInc.7271 Warden AvenueSuite 42/43Markham, ONL3R 5X5

Ravi JoshiTel: 1-905-604-8604Fax: 1-905-604-8605

[email protected] www.trilliumconsult.com

PharmaceuticalsBiopharmaceuticalsMedical DevicesOTC ProductsNatural Health ProductsCosmetics

Product Development

Regulatory Affairs

Qualification & Validation

Clinical Operations

Quality Assurance

Compliance Audits


Asia

List of ConsultantsThe list comprises consulting companies whose primary focus is Regulatory Affairs, Clinical Research, Quality Control or Compliance (GCP, GLP, GMP) forpharmaceuticals, biologics, veterinary drugs, medical devices, cosmetics, over-the-counter products, or natural health products. Companies are listedalphabetically by company name.

List of Acronyms:

DIN = Drug Identification NumberDMF = Drug Master File

GCP = Good Clinical Practice

GLP = Good Laboratory Practice

GMP = Good Manufacturing Practices

NHP = Natural Health Product

QA = Quality Assurance

QC = Quality Control

RA = Regulatory Affairs

SOP = Standard Operating Procedures

mailto:[email protected]:[email protected]://www.trilliumconsult.com/http://www.trilliumconsult.com/http://www.trilliumconsult.com/mailto:[email protected]


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Notes:

Clinical Trials Research includes conduct of trials (Phases I-IV), bioanalytical, data management and statistical services.

GCP includes guidance on requirements, preparation of SOPs, conduct of audits and GCP training.

GLP includes guidance on requirements, preparation of SOPs, conduct of audits and GLP training.

GMP includes guidance on requirements, preparation of SOPs, conduct of audits and GMP training.

Product Development includes guidance on requirements for moving through the therapeutic product development process.

Quality Assurance/Quality Control (QA/QC) includes arranging appropriate product testing and release.

Regulatory Affairs (RA) comprises review, assessment and preparation of appropriate regulatory documentation. Expertise in Clinical and/or Quality(chemistry and manufacturing) aspects is specified.

Toxicology includes nonclinical drug development and safety programs.

Disclaimer:

CAPRA / ACPR maintains this List of Consultants as a service to industry and to the regulatory authorities. The individual companies have provided theinformation on the list for presentation in a standard format. CAPRA / ACPR does not endorse any of the consultants on the list.

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