End to End Regulatory Services covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authority, Exigencies response, Pricing approval, Marketing Authorization Approval & Product Life Cycle Management.
Medical devices in India are categorized into A, B, C and D classes based upon the associated risk and Indian regulatory bodies have defined procedures for license applications. This includes rules for the import of medical devices.
DMF/ASMF/CEP scientific writing, Submission with Agency, support in resolving questions, Third Party API QP audit, QP audit Report, CAPA preparation, QP Declaration, CEP Certification, EDQM GMP support.
Product triggered GMP inspection from Malaysia, Regulatory Submission, MA Holding, ACTD dossier writing, Deficiencies closure, hand holding for GMP improvisation, Product approval & Site GMP accreditation, Market support.
BLA review, Scientific writing and CBER submission under 351(k) pathways with USFDA, Centralised application under Article 10(4) with EEA, Expert intelligence for biosimilar licensing in BRICS-TM markets.
With our core expertise in the area of quality, compliance and regulatory affairs, we provide technical consulting to financial institutions/ pharmaceutical companies to facilitate decision making for investment/ divestment projects.
Customised training for multiple technical topics based on current norms, GMP specialized training sessions, Regulatory training for product development, dossier writing, CTD management and Life Cycle Management.