Back

FIDES REGULATORY AFFAIRS ASSISTANCE

KATHODARA, KAMREJ
91-91-09913074242

Product Categories

Formulations
Oncology,Diabetology,CNS,Immunology,CVS,Metabolic Disorder,Respiratory,Vitamins/Minerals,Dermatology,Anti-Infectives,Opthalmic/Ontological,Anti malarials,HIV,AYUSH,Gunaecological,Urology,Vaccines,Pain/Analgesics,Hormones,Sex Stimulants/Rejuventators,Nutraceuticals
Regulatory Affairs Consultant
Services

Company Profile

Fides RAA regulatory consulting and intelligence team is, established in 2013 and with extensive experience in product development, preparation of global registration strategies and successful registration of products with regulatory authorities worldwide. We specialize in regulatory support and below niches: 1. Dossier Compilation and Submission Dossier Conversion (Non-CTD to CTD, ACTD, eCTD, NeeS, Country Specific or Regional Submission) 2. Contract Manufacturing Services 3. BA/BE Report / Studies Clinical Trials (Only Third party co-ordination) 4. Clinical Trial Application Services 5. Clinical Data Management 6. Technology transfer (All formulations & API) 7. Dossier Support (ACTD & CTD) 8. Clinical and pre-clinical expert reports. Module 3 quality Report 10. Drafting the MRA query during the registration procedures 11. Post approval Changes or re-registration for product life cycle management