Our Main Services

GMP Excellence : EU/ PICS/ TGA/ Health Canada

GMP pre-audits, Compliance advise and bridging support, QMS documentation, Facility upgradation advise, mock up inspection, QP audit, EU GMP inspection to certification hand holding, annual report submission.

Drug Product Regulatory – EU, UK, Australia, US, Canada, WHO & Emerging Markets

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.

Biosimilars & Vaccines Regulatory 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.

EDQM Preparation & API CEP/ DMF Services

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.

Third Party QP Audits, Vendor Qualifications & Due-Diligence

Third Party QP Audits, Vendor Qualifications & Due-DiligenceThird Party QP Audits, Vendor Qualifications & Due-Diligence

Portfolio Partnerships

Portfolio Projects across the value chain, ranging from market specific portfolio strategy, defining regulatory pathway,  product development, commercial launch & local partnership