Compilation of dossier as per latest country specific guidelines.
Dossier compilation as per :
- Common Technical Dossier (CTD) Guidelines.
- Asean Common Technical Dossier (ACTD) Guidelines.
- Country Specific.
Dossiers compilation for submissions in :
- Central America
- South America
- North America
Drafts data for :
- BMR, MFR
- Process Validation,
- Analytical Validation,
- Stability Study reports,
- Dissolution profile,
- Certificate of analysis and related reports
Reports on :
- Bioavailability / Bioequivalance Studies,
- Clinical Trials studies
- Justification for fixed dose combination
- Prepare Periodic Safety Update report(PSUR)
- Preclinical studies like Toxicity, Subacute, Acute, Carcinogenicity, Teratology and Reproduction toxicity.
Prepare Summary of product (SPC), Pack Insert, Product Rationale :
Expert Reports :
Overviews (Module 2) :
Nonclinical Study Reports (Module 4) :
Clinical Study Reports (Module 5) :