Pharmaceutical Dossiers

Expertise / Events / Other information

Free consultation: - pre-product registration / pre-dossier preparation inquiries

Special reduced charges for Indian Pharmaceutical SMEs and small manufacturer

Dossier conversion (from one country to another)

EUCTD and ASEAN CTD dossiers compilation and review

Ready dossier available for Asian, African and CIS market

MCC product registration

Dossier Services for 85 countries

Dossiers as per ASEAN CTD Guideline

Dossier in EUCTD format

Dossier as per latest regulatory guidelines (released by MOH)

Dossier Preparation: - Africa, Asia, CIS, Central America, North America, South America

Bioequivalence Studies

Animal Toxicological Studies

Stability Studies - Real time and Accelerated stability studies

Analytical Method Validation (Formulation and API)

Registration assistance

Pharmaceutical Technology - Know How

Assistance for Product Development

SmPC, Pack insert and PIL preparation

Clinical and Non-clinical Overviews