Portfolio Projects across the value chain, ranging from market specific portfolio strategy, defining regulatory pathway, product development, commercial launch & local partnership
- Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry
Archive
October 18, 2023
August 30, 2018
Third Party QP Audits, Vendor Qualifications & Due-Diligence
Third Party QP Audits, Vendor Qualifications & Due-DiligenceThird Party QP Audits, Vendor Qualifications & Due-Diligence
July 30, 2018
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.
May 29, 2018
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.
May 28, 2018
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.
May 27, 2018
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.