We are a one stop solution for Pharmaceuticals Regulatory Affairs as niche. Having highest capacity for dossier producing, our team comprise of total 18 people. Among them 11 trained professionals are dedicated to regulatory services only.
Fides Regulatory’ Services are:
1. Dossier Compilation and Submission Dossier Conversion (Non-CTD to CTD, ACTD, eCTD, NeeS, Country Specific or Regional Submission) for ASEAN, MENA, LATAM, EU, CIS, AFRICA, GCC and many row markets.
2. CTD dossier writing
3. BA/BE Studies & Clinical Trials
4. Clinical Trial Application in DCGI & BE NOC As per New Amendments from DCGI, INDIA
5. ACTD dossier writing
6. DMF-ASMF writing
7. Analytical Method Validation for Dissolution, Identification, Assay, Related Substances (Impurity) and Residual Solvent. (HPLC- with chromatogram, UV- with spectrum), Impurity Profile Validation
8. Comparative Dissolution Profile (HPLC- with chromatogram, UV- with spectrum).
9. Bio- analytical Validation / Report and Protocol along with ANOVA calculation for BA/BE report
10. Third party Co-ordination for Bioavailability / Bioequivalence / Clinical Trial Studies / Pre- clinical trial studies through well-established study centres for various dosage forms
11. List of countries handling presently : Nigeria, Ghana, Kenya, Rwanda, Uganda, Myanmar, Philippines, Cambodia, UAE, Saudi Arabia, Cameroon, Angola, Niger, Tanzania, Mozambique, Liberia, Madagascar, Burkina Faso, Ethiopia, Togo, Mali, Malawi, Burundi, Botswana, South Africa, Mongolia, Sri Lanka, Bangladesh, Malaysia, Vietnam, Uzbekistan, Tajikistan, Azerbaijan, Kyrgyzstan, Turkmenistan, Armenia, China, Hungary, Iran, Ukraine, Thailand, Romania, Kazakhstan, Indonesia, Georgia, Colombia, Egypt, Yemen, Syria, Russia, Zimbabwe
12. Product information updates (SmPC, PIL and Labelling).
13. Patient Safety Update Report, Pharmacovigillence Report, Risk management Plan
14. Dossier Audit with Risk Assessment grading
15. Product registration in various countries across the globe
16. Audits and Regulatory compliance
17. GMP /GLP AUDITS
18. 360o Documentation
19. Process Validation Services
20. Pharma Plant setup and Key Project
21. Complete SOP documentation
22. eCTD Publishing for Document level and and for Publishing level, DMF CEP, ANDA Submission
23. Structured Product Labelling (SPL) Services
24. Expert advice for Regulatory Operations planning / strategy / management like submission attributes, STF file tag, gap analysis, and life cycle operations, document tracking through eCTD checklist & document change history and eValidation troubleshooting with strict adherence to health authority requirements
25. eCTD with Country-wise and client-wise, experienced and qualified team for end to end Regulatory Operations service i.e. document level (DLP) and submission level publishing (SLP), additionally 24 x 7 client support (anytime and anywhere)
26. For eCTD services, Fides serve pharma / healthcare industry with all required standards of Regulatory Publishing i.e. tools (PDF toolbox, eCTD Software and eValidator), submission checklist (file naming, leaf title, life–cycle operation), quality review checklist (pre, intermediate and post compilation) etc.
27. All above services for Pharmaceuticals, Biopharmaceuticals, Biosimilars, Biotechnological, Neutraceuticals Products and also we assist in Cosmetic, Medical device, Herbal medicines, Traditional Medicines, Unani Medicines
28. Query support for all of above type of documents till registration
For your ready reference we have ready dossier list and documents list, kindly request you to let us know your exact requirement of DRA related any type of Query, we can send accordingly.
