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.

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.

Expert Reports

- Quality,
- Pre-clinical,
- Clinical

Overviews (Module 2)

- Clinical
- Non-Clinical

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)

Registration Assistance

Technology Transfer Dossiers Disposable
     Surgical Items