Responsibility of MYdossier.in for ASEAN CTD dossier...

MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma

Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)

Madanapalle -517 325, Andhra Pradesh India

Website:- http://www.mydossier.in; Email:- [email protected]

Responsibility of MYdossier.in for ASEAN CTD dossier preparation

1. We will follow latest format of registration guideline documents

2. We will use correct and appropriate information to prepare dossier

3. We will follow latest specification for API, FP and RM

4. We will take care of complete MOH queries (if raise during MOH registration)

5. NO additional consultancy fees will charge for solving MOH queries

How we are different from others for ASEAN CTD dossier preparation

1. Dedicated dossier developing facility in 30 ,000 sft

2. Most reasonable price with highest quality

3. Post sale support (free help for solving MOH queries – if raised during registration)

4. We know what to do and what not to do during CTD dossier preparation

5. We always take care of business interest of our clients





About MYDossier.in

MYdossier (Division of Zodiac Pharma) is an Indian based Export dossier registration consulting firm. We offer a wide range of

services in the areas of in the areas of Pharma dossier sale, regulatory affairs, handling MOH inquiry, and dossier training for small

to medium size pharmaceutical companies to help them to overcome the challenges within the rapidly evolving global pharmaceutical

market.

Mission: "To become a Research-based International Regulatory Affairs and dossier development centre"

Core Values : We are driven by a desire to excel and exceed customer expectations, provide a joyous working environment for our

people and empower them to think big and set ambitious goals. We want to achieve all this in an environment that promotes integrity.

Vision: "Achieving significant business in generic product dossier consultancy with a strong presence in non-regulated and semi-

regulated market (Asia, Africa, CIS, Latin America)"

Founder, CEO & Chief consultant – Mr. Tara chand Tak

All dossiers are prepared under guidance and observation of Mr. Tara chand Tak

He is also worked as regulatory affairs consultant for Global assessment of VMP registration

regulations (World Bank Group project tilted EBA).

His foresightedness can be well showed by his endeavors which area from Pharma dossier

sale, regulatory affairs, handling MOH inquiry, and dossier training for small to medium size

pharmaceutical companies to help them to overcome the challenges within the rapidly evolving

global pharmaceutical market.. He drives the company's vision, strategy and growth as it

provides interesting and unique ways for client and learner to serve their purpose.





He did his schooling from Jawahar Navodaya Vidyalaya (Pali) Rajasthan. He did his B.Pharm & M.Pharm from Manipal collage of

Pharmaceutical Sciences, Manipal University, Udupi, Karnataka. He also did certificate course in intellectual property rights from

World Intellectual Property Organization (WIPO), Geneva, Switzerland. After his postgraduate, he worked on the post of Executive in

Pharma MNC companies at Bangalore and Hyderabad. His core areas of during job were in dossier writing, global dossier

management and international marketing. During that period, he got opportunity to work with global leader – Pfizer, Ranbaxy,

Sandoze, Teva, Lupin, DRL, Mylan, Stride arcolabs, Apotex Canada etc.

More than 2000 CTD and ASEAN CTD dossier prepared under his guidance in past 5 years. He having more than 9

years experience in CTD dossier, ASEAN CTD and ROW dossiers.

YES WE CAN WE ARE MYdossier.in

India's MOST

RECOMMENDED dossier

consultancy





Key Feature

ASEAN CTD dossiers will compliance with current pharmacopeia

Process validation Stability data and COA will be complete

All MoH queries will handled by us

ASEAN CTD DOSSIER (As country specific guideline)

# Heading Description

PART-I ADMINISTRATIVE AND PRODUCT INFORMATION Provided/ Prepared / Compile / Drafted by

MYDossier.in

SECTION-A INTRODUCTION It need to prepared by Applicant at the time of

submission

SECTION-A TABLE OF CONTENTS Provided/ Prepared / Compile / Drafted by

MYDossier.in

SECTION-A DOCUMENTS REQUIRED FOR REGISTRATION It need to prepared by Applicant at the time of

submission or Application form need to send us for

drafting

1. Application Form

2. Letter of Authorization Provided/ Prepared / Compile / Drafted by

MYDossier.in

3. Certifications PIL/Pack insert will Provided/ Prepared / Compile /

Drafted by MYDossier.in

3.1 Manufacturing Licence Need to provided by applicant (if any)





3.2 GMP Certificate Resume need to send us

3.3 Certificate of Pharmaceutical product Manufacturer need to arrange

4. Labeling Provided/ Prepared / Compile / Drafted by

MYDossier.in

5. Product Information Provided/ Prepared / Compile / Drafted by

MYDossier.in

5.1 Package Insert Provided/ Prepared / Compile / Drafted by

MYDossier.in

5.2 Summary of Product Characteristics Provided/ Prepared / Compile / Drafted by

MYDossier.in

5.3 Sample for registration Provided/ Prepared / Compile / Drafted by

MYDossier.in

PART-II QUALITY DOCUMENT Provided/ Prepared / Compile / Drafted by

MYDossier.in

SECTION-B TABLE OF CONTENTS Provided/ Prepared / Compile / Drafted by

MYDossier.in

SECTION-B QUALITY OVERALL SUMMARY Provided/ Prepared / Compile / Drafted by

MYDossier.in

S DRUG SUBSTANCE Provided/ Prepared / Compile / Drafted by

MYDossier.in

P DRUG PRODUCT Provided/ Prepared / Compile / Drafted by

MYDossier.in

SECTION-C BODY OF DATA Provided/ Prepared / Compile / Drafted by

MYDossier.in

S DRUG SUBSTANCE Provided/ Prepared / Compile / Drafted by

MYDossier.in

S 1

S.1.1

General Information

Nomenclature

Provided/ Prepared / Compile / Drafted by

MYDossier.in





S.1.2

S.1.3

Structural formula

General properties

S 2

S.2.1

S.2.2

S.2.3

S.2.4

S 2.5

S 2.6

Manufacture

Manufacturers name

Brief description of Mfg process & Route of synthesis

Control of materials

Control of critical steps and intermediates

Process validation

Manufacturing process development

S.2.1 & S.2.1 will provided; remaining are closed

part of DMF which will provided (as it’s not

required).

S 3

S.3.1

S.3.2

Characterization

Elucidation of structure and other Characteristics

Impurities


MYDossier.in

S 4

S.4.1

S.4.2

S.4.3

S.4.4

S.4.5

Control of drug substance

Specification

Analytical procedures (AP)

Validation of Analytical procedures

Batch Analyses

Justification of specification.


MYDossier.in (except S.4.3)

S 5 Reference standards or Materials. Provided/ Prepared / Compile / Drafted by

MYDossier.in

S.6 Container Closure System Provided/ Prepared / Compile / Drafted by

MYDossier.in

S.7 Stability data Provided/ Prepared / Compile / Drafted by

MYDossier.in

P DRUG PRODUCT Provided/ Prepared / Compile / Drafted by

MYDossier.in

P.1 Description and composition of the drug product

a) Description


MYDossier.in





b) Dosage form and Characteristics

c) Description of Reconstitution diluents (If any)

d)Type of container and closure system

e) Composition

P.2 Pharmaceutical Development Provided/ Prepared / Compile / Drafted by

MYDossier.in

P.3

P.3.1

P.3.2

P.3.3

P.3.4

Manufacture

Batch Formula

Description of Mfg process & Process control.

Control of critical steps & intermediates.

Process Validation


MYDossier.in

P.4

P.4.1

P.4.2

P.4.3

P.4.4

Control of Excipients (Excipients)

Specification

Analytical procedures (AP)

Excipients of human or animal origin

Novel Excipients


MYDossier.in

P.5

P.5.1

P.5.2

P.5.3

P.5.4

P.5.5

P.5.6

Control of Finished Product

Specification

Analytical Procedure

Validation of analytical procedure

Batch Analyses

Characterization of Impurities

Justification of specification


MYDossier.in (except P.5.3, only protocol will

provided)

P.6 Reference standards or Materials. Provided/ Prepared / Compile / Drafted by

MYDossier.in

P.7 Container Closure system Provided/ Prepared / Compile / Drafted by

MYDossier.in

P.8 Stability data Provided/ Prepared / Compile / Drafted by





MYDossier.in

P.9 Product Interchangeability equivalence evidence Provided/ Prepared / Compile / Drafted by

MYDossier.in

PART-III NON CLINICAL DOCUMENT (literature based) Provided/ Prepared / Compile / Drafted by

MYDossier.in

PART-IV CLINICAL DOCUMENT (literature based) Provided/ Prepared / Compile / Drafted by

MYDossier.in





Thanking you

MYdossier.in Dossier Consultancy Division,

Zodiac Pharma

Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli,

(On Sate Highway No 219) Madanapalle -517 325,

Andhra Pradesh India

Website:- http://www.mydossier.in

To get more information (quote or inquiry) – Direct contact to Mr. Tara chand Tak

CALL, SMS or Whatsapp to +91-965-22-81-81-4 'OR' Email:- [email protected]

http://www.mydossier.in/

mailto:[email protected]









In Sept 2016 - Mr. Tara chand Tak, Founder & CEO of MYdossier attended seminar as SPEAKER. He has share his expertise

on topic "Healthcare product registration strategy for Cambodia - Challenges and Opportunity"





In Sept 2016 - In association with VEAS, Vietnam and Cambodia Phar-Med Expo 2016 , MYdossier / Mr. Tara chand Tak

provided free consultancy services to Exhibitors and Visitors.





July 2016 - Mr. Tara chand Tak visited Yangon as Speaker (for event Pharma Med 2016, Myanmar) to share his expertise on

Export management in ASEAN countries.

Date post:	30-May-2020
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