Regulatory Affairs

Evolet

Over the years Evolet has gathered a team of highly committed and experienced Regulatory affairs professionals. It reviews in house documentations and updating other departments. It is the interface between the company and the regulatory authorities.

It assures the efficacy, safety, and quality of the product. Regulatory Affairs is involved in the development of new medicinal products, by applying regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities within the specified time period.

Our Regulatory Team having invaluable experience makes smooth roadways for placing quality product in market and has helped us in obtaining registration of more than 350 products across the countries of CIS, South Asia and Africa.

Our regulatory team keeps track and update the company with always changing regulatory guidelines/ requirements of the region where the product is to be sold.

Evolet have Common Technical Document (CTD) dossiers, enabling compliance with various health authorities.

Approvals

Depending on the needs of the customers, we work closely with all kinds of reliable and efficient drug manufacturers.

Our manufacturing plants are approved by the following:
USFDA | EU-GMP| ANVISA | TGA | WHO-GMP | UKMHRA | PIC/s