Serving India and South East Asia, Groupe Athena has been serving companies abroad in obtaining FDA approval for pharmaceuticals, medical products and devices for export to America. Our goal is to ensure each of our clients passes FDA inspection by assisting them from concept through development, with consultation through all the regulatory requirements, filings, and processes to achieve FDA compliance and approval.
With offices in India and America, the expert consultants of Groupe Athena are in position to go to target companies in Asia and the regulatory authorities in the USA directly, consulting with our clients in the East to serve them completely in providing consultancy services for FDA compliance. Services include providing technical and regulatory consulting for biotechnical products, pharmaceuticals [over the counter, prescription and generics], diagnostics, medical equipment, and devices.
The FDA inspection process is traditionally complicated, especially for foreign drug and medical companies trying to export to the USA. With broad spectrum consultancy and assistance through this process, our client base can count on reduced risk, follow-through on steps necessary for FDA compliance and identifying and solving breaches in compliance.
From concept through final approval, Groupe Athena navigates companies through every requirement of the process including pharmaceutical consulting, development, and regulatory compliance to achieve FDA approval and export pharmaceuticals and medical products and equipment to the USA.
- Analytical QC
- QA Functions
- Readiness for Inspections
- Clinical Trial Management
- Preparation of Regulatory Filings (IND’s/PMA’s/NDA’s/ANDA’s/510Ks etc)
- Compliance Assessments (GLP, GMP, GXP)
- Risk Assessments
- Mock FDA Audits
- Medical Device Support
- CMC Support
- GMP Training
- Facility Layout Consulting
- Utilities, Process, IT, Computer, and Cleaning Validation