FDA Regulatory Consultant
FDApals providing expertise on USFDA and EU Regulation for FDA Registration of FOOD, Medical Device, Drugs and Cosmetics.
- Drug Master File ( DMF) Filing & Preparation for API,Excipient and Packing Material
- Medical Device FDA Approval in USA, Europe, Canada, India & China
- FDA Approval & Registration – ( FOOD, Supplements, Drugs, Cosmetics)
- eCTD Publishing services for ( CTD Dossier, IND, ANDA, NDA)
- EU Variation Filing Type I & II, USFDA Amendment and Annual Reports
- US Agent Services
- CE Marking, ISO 13485, ISO 15378 & GMP Audits + Trainings
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Min project size
Undisclosed
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Hourly rate
$25 - $49 / hr
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Employees
10 - 49
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Year founded
Founded 1990
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