API FIRST is a pharma regulatory consulting service which deals with Drug regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries.
Drug filing process also includes complete technical and administrative review of the data submitted. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process.
We provide complete start to finish solutions of drug approval process in India.
Apart from drugs, our regulatory services are extended to cosmetics, medical devices, ethics committee registration etc.
Additionally, we have separate and dedicated teams handling the layout designing of drugs and nutraceuticals manufacturing plants as per GMP requirements of USFDA, MHRA, EU, TGA, PIC/S, WHO, Schedule M etc.
We also provide various other services like:
- GMP trainings, conduct third party audits, legal services,
- helps in QMS implementation, project management,
- Regulatory retainership
- support as Authorized agent and product distribution
Licensure support
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