Regulatory Strategy Consulting

The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality of drugs. Global Regulatory Strategy Consulting for pharmaceuticals is essential to streamline submissions, accelerate approvals, and bring innovative medicines to market.

Regulatory Consultancy

Dossier Compilation & Submission
- Preparation of CTD, ACTD, and country/region-specific dossiers for ASEAN, CIS, AFRICA, GCC, and ROW markets.
CTD Dossier Writing
- End-to-end authoring and formatting of regulatory dossiers.
Drug Master File (DMF)
- Compilation of Open Part and Closed Part for regulatory agencies.
BA/BE Studies & Clinical Trials
- Design, conduct, and reporting of Bioavailability/Bioequivalence studies and clinical documentation.
Analytical Method Validation
- Validation of methods for Dissolution, Assay, Related Substances (Impurities), and Residual Solvents
  (HPLC with chromatograms, UV with spectra).

Comparative Dissolution Profile (CDP)
- CDP reports supported with HPLC chromatograms and UV spectra.
Bioanalytical Validation & Reports
- Protocol preparation, validation reports, and ANOVA statistical analysis for BA/BE studies.
Product Information Updates
- Drafting and updating SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflets).
Pharmacovigilance Services
- PSUR (Patient Safety Update Reports)
- RMP (Risk Management Plans)
- PSMF (Pharmacovigilance System Master File)
- SOP development for pharmacovigilance & surveillance activities
Legalization & Document Services
- Embassy & Apostille legalization
- Submission & collection of documents with CDSCO (Neutral Code applications)