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Dossier compilation as per :
- Common Technical Dossier (CTD) Guidelines.
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Guidelines.
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Drug master file (DMF) compilation for
open and closed parts.
Drafts data for
- BMR, MFR
- Process 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 &
Reproduction toxicity
Prepare Summary of product (SPC),
Pack Insert, Product rationale.
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Overviews (Module 2)
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Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)
Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.
Dossier conversion from one country to another)
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