Product Description

We provide complete solutions of registration from initial to final stage manufacturer / applicant for:
Dossier compilation as per:
• ASEAN Common Technical Dossier (ACTD) Guidelines
• Common Technical Documents as per ICH format
• Regional Format (Country Specific)
Handling queries
Draft query reply
Registration Management
Documents Review
• BMR, MFR
• Process Validation reports
• Analytical Validation reports
• Stability Study reports,
• Dissolution profile,
• Certificate of analysis and related reports
Writing 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
Prepare Expert Reports:
• Quality,
• Pre-clinical,
• Clinical
Our customized services
• Interaction with regulatory authorities
• Preparation and conduct of meetings with authorities
• Development of Product regulatory strategies
• Preparation of development plans
• Project planning for regulatory activities through all phases of drug development
• Preparation and review of Module 1 CTD documents (e.g. application form, proposed product information and drug labeling)
• Preparation, review and submission of regulatory documents in CTD documents
• Evaluation of technical data prior to submission (quality, clinical and non-clinical documents)
• Management of follow up activities after submission