Regulatory Affairs Service
Drug Regulatory Affairs concerns all aspects of pharmaceutical product development, registration, and commercialization. With regulatory experience spanning all areas of pharmaceuticals, our regulatory specialists provide intelligence and strategic insight to optimize your product’s success.
Our comprehensive Regulatory services including:
FOR GMP COMPLIANCE
- Third-party GMP consulting and GLP compliance auditing.
- Mock international regulatory agency inspections, and PAI readiness.
- Due diligence compliance inspections, audits, and assistance.
- Qualification and validation.
- cGMP training.
FOR DRUG SUBSTANCE
- Development (preparation) and registration DMF with China, and major regulatory agencies globally.
- China DMF,USDMF,and CEP applications.
- Life cycle management — variations, revisions, renewals.
FOR FINISHED PRODUCT
- Pre-submission and/ or scientific advice procedures at regulatory authorities
- Dossier evaluation and gap analyses
- Writing chemical-pharmaceutical documentation (CMC, Module 3)
- Preparation, submission, and management of all types of Marketing Authorization Applications.