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.
- We assist 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.
- To prepare regulatory submissions and ensure that the information and data to be conveyed and discussed with the regulatory agencies are presented in the right way and right form.
- Managing advisory meetings and scientific advice from agency.
- Updating on regulatory agency alerts & warnings.
- Global submissions and regulatory assistance for Australia, New Zealand, Europe, US, Canada and South Africa.
Australia & New Zealand
- 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
Europe
- 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
USA
- 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
Canada
- 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