Regulatory Services
Regulogix provides highest standards for regulatory submissions which are the most critical milestones in the business process of the lifescience sector. Our experienced regulatory team understands that you get one chance at a submission and ensures that all deliverables meet regulatory guidance standards. Our area of expertise are :
Dossier Preparation and submission : for different segments Pharmaceuticals, Nutraceuticals, Veterinary, Biotech Products, Vaccine, and Medical devices:
Preparation of the quality dossier (planning, preparing, updating, reformatting)
Preparation of pharmacological/toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.
Communication with regulatory authorities
Monitoring of deadlines
Variations
Reformatting NtA to CTD and CTD to eCTD
Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.
Dossier conversion (from one country to another)
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 / Bioequivalence Studies,
Clinical Trials studies
Justification for fixed dose combination
Prepare Periodic Safety Update report (PSUR).
Preclinical studies like Toxicity, Carcinogenicity, Teratology & Reproduction toxicity.
Prepare Summary of product (SPC), Pack Insert, Product rationale.