SERVICE - img. ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines

SERVICE - img. ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines
SERVICE - img. ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines
SERVICE - img. ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines
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Transcript of SERVICE - img. ASEAN Common Technical Dossier (ACTD) Guidelines South Africa (MCC-MRF-1) Guidelines

  • 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)

  • 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

  • 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