SERVICE - img.tradeindia.com · ASEAN Common Technical Dossier (ACTD) Guidelines South Africa...

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SERVICE We assist manufacturer / applicant for: Dossier Services Φ Dossier Review Φ Application Drafting Φ Handling MOH queries Φ Draft query reply Φ Registration Management Compilation of dossier as per latest country specific guidelines. Dossier compilation as per: ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines Brazil ANVISA Guidelines Drafts data for: BMR, MFR Process Validation, Analytical Validation, Stability Study reports, Dissolution profile, Certificate of analysis and related reports Reports on: Bioavailability / Bioequivalence Studies, Clinical Trials studies Justification for fixed dose combination Prepare Periodic Safety Update report (PSUR) Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity. Prepare Summary of product (SPC), Pack Insert, and Product Rationale: Expert Reports:Quality,Pre-clinical,Clinical Overviews (Module 2): Clinical Non-Clinical Nonclinical Study Reports (Module 4): Clinical Study Reports (Module 5)

Transcript of SERVICE - img.tradeindia.com · ASEAN Common Technical Dossier (ACTD) Guidelines South Africa...

Page 1: SERVICE - img.tradeindia.com · ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines Brazil ANVISA Guidelines Drafts data for: BMR, MFR Process Validation,

SERVICE

We assist manufacturer / applicant for:

Dossier Services Φ Dossier Review

Φ Application Drafting

Φ Handling MOH queries

Φ Draft query reply

Φ Registration Management

Compilation of dossier as per latest country specific guidelines.

Dossier compilation as per:

ASEAN Common Technical Dossier (ACTD) Guidelines

South Africa (MCC-MRF-1) Guidelines

Brazil ANVISA Guidelines

Drafts data for: BMR, MFR

Process Validation,

Analytical Validation,

Stability Study reports,

Dissolution profile,

Certificate of analysis and related reports

Reports on: Bioavailability / Bioequivalence Studies,

Clinical Trials studies

Justification for fixed dose combination

Prepare Periodic Safety Update report (PSUR)

Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity.

Prepare Summary of product (SPC), Pack Insert, and Product Rationale: Expert Reports:Quality,Pre-clinical,Clinical

Overviews (Module 2): Clinical

Non-Clinical

Nonclinical Study Reports (Module 4): Clinical Study Reports (Module 5)

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INDUSTRIES We provide our services to below industries:

Φ Pharmaceutical Formulation

Φ Pharmaceutical APIs / Bulk drugs

Φ Nutraceuticals

Φ Herbal

Φ Cosmetic

Φ Veterinary

Φ Biotech

OFFERS We are providing services by reducing its basic price.

Purpose of Discount and Sale

Φ Rewarding to valuable customers

Φ Promotion of Mittal Services

Φ Encouraging distribution channel

Φ Creating new market

Φ Increase short-term sales

Φ Encouraging to entrepreneurs / new exporting companies

OUR EXPERTS

Technical Team: S.B.Mittal, M.Pharma (Pharma.Management & Regulatory Affairs)

M.B. Mishra, MBA. (International Business)

P.K. Aggarwal, M.S. (Formulation & Analytical Development) London (U.K.)

Nitin Kadyan, M.Pharma. (Pharmaceutics)

Vivek Jaglan, M.Pharma. (Pharmaceutics

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COUNTRIES REGISTRATION

Asia Africa North America South America Central America

CIS countries

Afghanistan Algeria Argentina Azerbaijan Bangladesh Benin Bolivia Belarus Cambodia Botswana Chile Georgia China Burkina Faso Costa Rica Kazakhstan Hong Kong Cameroon Cuba Kyrgyzstan India Chad Dominican Republic Russia Indonesia Congo Ecuador Tajikistan Iran Egypt El Salvador Turkmenistan Iraq Ethiopia Guatemala Ukraine Jordan Gabon Guyana Uzbekistan Lebanon Gambia Haiti Mongolia Ghana Honduras Malaysia Ivory Coast Jamaica Myanmar Kenya Mexico Nepal Madagascar Nicaragua Philippines Malawi Panama Saudi Arabia Mali Peru Singapore Mauritania Suriname Sri Lanka Mauritius Trinidad Syria Mozambique Uruguay Thailand Namibia Venezuela Vietnam Nigeria Yemen Senegal Algeria