INDIA
Amarant Lifesciences, a regulatory consultant, provides clear strategies for timely product filings and registrations. With our in-depth knowledge of the Indian regulatory landscape, we can help you navigate the intricacies and achieve your goals smoothly. Trust Amarant for end-to-end assistance with CDSCO, MOH, AYUSH, and associated regulatory bodies.
Services We Offer
- Strategic regulatory consultation
- FDA registration for import of Drugs / APIs in India
- Site registration with CDSCO India
- Cosmetic Registration for import in India
- New product license for manufacturing in India
- FSSAI registration (Food & Ingredients registration in India)
- BE Studies NOC
- IVD & Medical device registration
- Regulatory affairs & regulatory intelligence
- Test License for Importing finished Formulation and APIs
- Dossier (preparation, evaluation, and compliance)
- Registration pathways and license management services
- Authorised agent services
- Import licences
- Marketing authorization applications, renewals, transfers & life cycle management
- End-to-end registrations
- GMP, GLP, GCP, GDP, GVP audits (GxP)
- Periodic safety update reports (PSURs), Addendum to clinical overviews (AtCOs)
- Medical Writing: investigator brochures, clinical trial protocols and clinical study reports, CTD modules, safety narratives, CSR writing, protocols
- Review of advertisements, promotional materials & Product claims assistance based on Scientific literature/ Clinical trial studies/ Nutritional studies