Regulatory Submissions

We believe in timely submissions with quick approvals and maintenance of regulatory submissions in the complex and rapidly changing regulatory environment. Our team of regulatory experts absolutely supports clients to gain competitive edge in business.

  • Assistance in regulatory submission process from product design to approval and maintaining product life cycle according to the client’s need
  • Analysis of regulatory pathways and challenges to obtain successful approval
  • Regulatory data submission and communication in right way and in right form
  • Management of advisory meeting with regulatory agency
  • Update on regulatory agency alerts and warnings
  • Global submissions and regulatory assistance for Australia, New Zealand, Europe, US, Canada and South Africa
  • Project Management
  • Handling Pre-submission, Submission, Query Response, Variations and Life Cycle Management in Australia
  • Handling New Medicine Applications by Abbreviated Route/Full Route Applications, Query Response, Changed Medicine Notifications and Life Cycle  Management in New Zealand
  • Managing GMP requirements and Submission Tracking
  • Due diligence and review of the dossier
  • Advice on requirements of Bioequivalence studies and Biowaiver claims
  • Technical advice on data requirements for the dossier and writing scientific justifications
  • Module 1 preparation
  • Complete Dossier preparation and submission for Prescription and OTC medicines
  • Expert Report: Preparation of Quality, Non Clinical and Clinical Overview and Summary
  • Conversion of dossier – NeeS to eCTD
  • eCTD Publishing and Management
  • Project Management
  • Managing Scientific Advice from EU Agencies, Slot booking and Submissions for DCP, CP, MRP, National procedures
  • Managing Readability Testing, Proof Reading, National Translation and Artwork Preparation.
  • Handling National Phase Submission
  • Qualified Person, Batch Testing and Batch Release
  • Pharmacovigilance Services
  • Due diligence and review of the dossier
  • Advice on requirements of Bioequivalence studies and Biowaiver claims
  • Technical advice on data requirements for the dossier and writing scientific justifications
  • Module 1 preparation
  • Complete Dossier preparation for Prescription medicines
  • Expert Report: Preparation of Quality, Non Clinical and Clinical Overview and Summary
  • eCTD Publishing and Management
  • Conversion of dossier – Non CTD to CTD, CTD to eCTD
  • Query response preparation and submissions
  • Life cycle management- Variation Applications, Sunset Exemptions and Renewals
  • API – ASMF & CEP preparation and submission
  • Project Management
  • Managing Scientific Advice from USFDA and Submissions for ANDA, NDA & DMF
  • Due diligence and review of the dossier and DMF
  • Advice on requirements of Bioequivalence studies and Biowaiver claims
  • Technical advice on data requirements for the dossier and writing scientific justifications
  • Module 1 preparation, Patent Certification, Declarations and Structured Product Labeling
  • Complete Dossier preparation for Prescription medicines
  • Preparation of Quality, Non Clinical and Clinical Overview and Summary
  • eCTD Publishing and Management
  • Query response preparation and submissions
  • Life cycle management- Amendments, Supplements and Annual Reports
  • Project Management
  • Managing Scientific Advice from Health Canada and Submissions for ANDS, NDS & DMF
  • Due diligence and review of the dossier and DMF
  • Advice on requirements of Bioequivalence studies and Biowaiver claims
  • Technical advice on data requirements for the dossier and writing scientific justifications
  • Complete Dossier preparation for Prescription medicines
  • Preparation of Quality, Non Clinical and Clinical Overview and Summary
  • eCTD Publishing and Management
  • Query response preparation and submissions
  • Life cycle management – Variations and Annual Reports