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 dossiers as per latest country specific guidelines.

Dossier compilation as per: ASEAN Common Technical Dossier (ACTD) 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)

For dossier price quote or information, please write email to us: - mittalpharma5@gmail.com