KPS CLINICAL SERVICES PVT. LTD.(Contract Research Organization)

KPSClinical Services

Bestowing Research to Life

www.kpsclinicalservices.com

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Together Everyone Achieves More

ORGANOGRAM

Managing Director

CEO & Director

Clinical Operation

Project Manager

DeputyManager

Clinical Trial Lead

SeniorCRA

CRA

CTA Trainee

Trainee Trainee Trainee Trainee Trainee Trainee Trainee Trainee

Manager

AssistantManager

Sr.Executive

Executive Executive Executive Executive Executive Executive Executive

AssistantManager

Sr.Executive

AssistantManager

SeniorMedicalWriter

MedicalWriter

AssistantManager

Sr.Executive

Sr.Executive

Sr.Executive

Sr.Executive

Sr.Executive

AssistantManager

AdminOfficer

ITOfficer

AssistantManager

Manager Manager Manager Manager Manager Manager Manager Outsourcing

Quality Assurance

MedicalWriting

Buissness Development

Human Resource Admistration IT Legal Ancillary

ServicesDrug

Regulatory Affairs

ACCREDITATIONWe are an ISO 9001:2008 certified company ■Our BA/BE Centre Inspected and Approved by DCGI ■

KPS Clinical Services (KPSCS) is set up by the RAHE Group, with an aim to become one of the India's leading research-based Contract Research Organization (CRO). Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device companies, academic and government organizations.

We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavor, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by KPSCS are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.

ABOUT US

Our vision is to become leading drug development solution provider by delivering apposite services to the global healthcare industry.

We believe in our values & have established competency:

To provide a nurturing work culture that stimulates ■professional excellence through training.To achieve authorization with accountability and ■recognition.To provide a fair return on investment to KPSCS’s ■investors by driving exponential growth.To enable delivery of new medicines, while ■maintaining the most eminent ethical measures and be a creditworthy corporate national.

VISION

MISSION

Innovation Excellence Service Excellence TrustworthinessContinuous Learning Integrity Community Responsibility CompassionQuality Work Environment

VALUES

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ServiceSServiceS

KPSCS staff comprise of highly qualified and experienced professionals who manage all aspects of Phase I to Phase IV studies including:

Development of essential clinical trial documents ►(Protocol, ICD, CRF and Investigator Brochure).Feasibility of clinical trial studies. ►Investigator site selection and management. ►Monitoring and audit of clinical trial site. ►Clinical trial material logistics and management. ►Analysing and preparation of clinical study ►reports.Responding to regulatory agency’s request for ►information pertaining to product safety.

DIVISION OF CLINICAL TRIAL EXECUTION

DIVISION OF BIOEQUIVALENCE STUDY CENTER

KPS Clinical Services Pvt. Ltd. has been established own 32-beded Bioavailablity / Bioequivalence study center in the campus of RV Northland Institute, Greater Noida.

MAJOR CLIENTS

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ServiceS

KPSCS provides regulatory affairs consultancy tailored to meet client’s specific needs. Client’s data security and confidentiality is assured to the highest level.Our regulatory team have significant global experience in development of Dossiers, Drug Master File (DMF), and Common Technical Document (CTD).We provide services from submission to final approval of regulatory documents at the office of DCG(I), FDA Bhawan, New Delhi. We facilitate the guidelines for getting approval / N.O.C. for following applications:

Bulk Drugs ■Finished Formulations ■Medical Devices ■Vaccines ■

In short, we serve the entire spectrum of regulatory needs for our clients, based on experience and knowledge.

DIVISION OF REGULATORY AFFAIRS

DIVISION OF TDM & CLINICAL DATA MANAGEMENT

At KPSCS, we ensure that timelines are met and quality is maintained. Responsibilities, processes and expectations are clearly defined at an early stage for a smooth Therapeutic Drug Monitoring & Clinical Data management execution.

KPSCS offers services for management and execution of Therapeutic Drug Monitoring & Clinical Data Management from single center to multi-centeric studies in a variety of therapeutic areas.

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ServiceSDIVISION OF MEDICAL WRITING & TRANSLATION

KPSCS provides a wide variety of Post-Marketing Surveillance services that help the sponsors in collecting, comparing, processing, tracking, and reporting the possible adverse events to determine safety of products. Generally, post marketing surveillance is done in the Phase-IV of the clinical trial.

Call Centre services to sort and compile adverse ►event dataLiterature search ►Data processing and reporting to regulatory ►authoritiesPeriodic Safety Update Reports (Preparation of ►PSURs)Preparation of Individual Case Safety Reports ►(ICSR)

DIVISION OF POST MARKETING SURVEILLANCE

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KPSCS offering all medical writing services from Phase I to IV clinical studies. Our medical writing team comprises of physician and pharmacologists who have experience in developing documents in various therapeutic areas such as Oncology, Cardiology, Ophthalmology, Diabetolgy, Dental Science, Neuropsychiatry, Respiratory Disorders, Infectious Diseases, Dermatology, Hematology, Nephrology, Cosmetology, Ophthalmology, Antimicrobiological Agents and Herbal Drugs.

Our team have expertise in scientific writing, abstracts, posters, manuscripts and SOPs development. Documents are prepared strictly in accordance with ICH/EU/US guidelines and regulations.

The medical writing group has access to excellent translating services ranging from patient information sheet, Patient Diaries, ICD, CRF, Product Labels, Pharmacology Reports, Toxicology reports, Clinical Study Reports (CSR) and Investigator Brochures.We are providing translation services in 70+ languages.

ServiceSDIVISION OF TOXICOLOGICAL STUDIES

KPSCS provides pre-clinical laboratory research services supported by state of the art facilities worldwide. we can conduct individual studies to customer specification and also provide goal driven, consultative study design and execution. KPSCS conducts research in niche areas of toxicology such as:

System toxicology & Health risk assessment ■Nanotherapeutics & nanomaterial toxicology ■Environmental toxicology ■Food, Drug & Chemical toxicology ■

KPSCS offering their services to the pharmaceutical, biotech, medical device, agrochemical or chemical industries as well as Universities, Government and other research organizations.

KPSCS has a rich experience in performing Pre-clinical studies with expertise ranging from acute studies to more complicated multiple phased studies.

Acute/subacute toxicology studies ■Chronic toxicology studies ■Allergic Sensitization ■Carcinogenic and Mutagenic ■

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ServiceSAnimal Facility performs in-vivo tests for quality control evaluation of biologicals. The Facility ensures timely availability of lab animals for various in vivo tests by planned breeding program or by procuring animals from other CPCSEA registered sources. Animal Facility ensures high quality animal husbandry and care that meets the requirements of animal welfare regulations and guidelines provided by CPCSEA. Regular Institutional Animal Ethics Committee (IAEC) meetings are held to obtain ethical clearance for use of animals in QC testing.

Currently, the following animal strains are maintained

Mice ■Rats ■Rabbits ■Guinea Pigs ■

ANIMAL HOUSE

MAJOR AREAS FOR TOXICOLOGICAL STUDIES

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Medical devices (Syringes, Catheters, Blood transfusion ►sets, Dialysis units, Gloves, Sutures etc.).Genetically Modified crops and Genetically modified ►organisms.Contraceptives (Copper T, Tubal rings, Condoms etc.). ►

Herbal formulations and Ayurvedic drugs. ►Bulk Drugs and Pharmaceuticals. ►Dyes and Dye intermediates. ►Cosmetics. ►

ServiceS

OTHER SERVICES

Our toxicology laboratory is well equipped with wide range of instruments for various Biochemical, Histopathological and Haematological investigation:

Haematology Analyzer ►Biochemistry Analyzer ►Various microscopes including inverted ►microscopeUV/Visible Spectrophotometer ►Urine Analyzer ►CO ► 2 IncubatorAutomatic Tissue Processor ►Deep freezer ►Microtome ►Centerifuge ►HPLC ►

Post Marketing Surveillance ►Safety Assesment Studies ►Food Suppliment Assesment ►Health Survey ►

INSTRUMENTS

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Instrumentation Laboratory provides the most comprehensive and valuable solutions for your testing needs. Our technology is revolutionizing whole blood and hemostasis testing. Discover how our laboratory and point-of-care instruments, assays and reagents are setting the pace - with more capabilities, more end-to-end automation and more convenience - saving time and helping deliver the best possible patient care. Our facilities comprises of:

Hemostasis Diagnostics ■Critical Care Diagnostics ■Clinical Chemistry ■

Accuracy, Intelligence, Speed, Simplicity

DIVISION OF bioequivalence

Clinical Pharmacology Unit (CPU)

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32 bed Volunteer Housing Unit Intensive Care Unit Volunteer Counselling Unit

Mess AreaSample Processing Unit Subject Screening Unit

Phlebotomist AreaQuality Assurance Bio Analytical Unit

We are in “VOLVO - AGE”. Everywhere healthcare facilities are playing a predominant role in providing appropriate platform to take off and reach the dream world of health and wellness. At KPS Clinical Services Pvt. Ltd., we provide variety of services for pre-clinical, BA/BE, clinical study conduct and thier management and regulatory affairs at global level.KPS Clinical Services is a pioneer in the concept to develop a way of cost effective execution of various Research Projects to Pharmaceutical, Biotechnological, Medical Device Companies including Academic and Government Organizations.

We believe in applying innovative technologies and therapeutic expertise with a commitment to enhance quality of life to meet our corporate ethics. Our strategic hierarchy aims in maximizing return of our sponsors on investment and accelerate the delivery of safe and effective therapeutics to patients.

We wish to focus on the prevailing issues in clinical research and works to provide their solutions with a fresh and rational approach. In this endeavor, we have been successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel.

The services provided by KPS Clinical Services are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. As a result of our tireless efforts in the past and through the future, we are continuously developing and moulding our strength to deliver best services to our client.

Thanking YouBest Regards,Mukesh KumarCEO & Director- Clinical Operations

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KPS CLINICAL SERVICES PVT. LTD.S-203/204, II Floor, Meridian View Plaza, Alpha Commercial Belt, Alpha-I,Greater Noida (NCR), G.B. Nagar, U.P. (India)- 201306Ph. 0120-4231720 / 21 Fax: 0120-4213840Email: contact@kpsclin.com Web: www.kpsclin.com, www.kpsclinicalservices.com

KPSClinical Services

Bestowing Research to Life