Central Regulatory Services

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Central (CDSCO/DCGI) regulatory services:

Adroit provides quality services to the clients who are interested to launch their innovative products in India and also provides a cost effective method to get the approvals from the regulatory agencies in a smooth and easy way.

Our knowledge of the laws and regulations obtaining to the testing, approval, manufacturing, commercialization and post-marking surveillance of a product.

We offer regulatory services to below divisions:
  • Drugs
  • Medical devices
  • Biologicals
  • Cosmetics and disposables
  • Dual use NOC application for other products (Not medicinal).
The services include for Drugs:
For New drugs/ Subsequent new drugs/ Fixed dose combinations.
  • Registration Certificate application in India (CDSCO)
  • Import License application (For new products and existing products).
  • Authorized Agent/Registration Holder Support.
  • Marketing Authorization.
  • Test License application.
  • Re-Registration application.
  • Post approval changes .
  • Dual use NOC applications.
The services include for Medical devices:
For Class A, B, C & D medical devices and in vitro diagnostic devices.
  • Registration Certificate application in India (CDSCO).
  • Import License application (For new products and existing products).
  • Authorized Agent/Registration Holder Support.
  • Marketing Authorization.
  • Test License application.
  • Re-Registration application.
  • Post approval changes .
  • Dual use NOC applications
The services include for Biologicals:
For Vaccines, blood products, stem cells and cell based products.
  • Registration of the products.
  • Import Licensing process (New and existing).
  • Re registration process .
  • Post approval changes .
  • Test application .
  • Form 9 applications for import license application of already registered products (Biologicals includes vaccines, blood products and stem cell based products).
The services include for cosmetics:
For cosmetics (Skin care, hair care and other products)
  • Registration of the products.
  • Import Licensing process (New and existing).
  • Re registration process .
  • Post approval change .
The services include for Dual use NOC application (Not medicinal):
  • These services include dual use NOC application for non-medicinal substances and medicinal products, follow-ups. Adroit will finish this application process within in a span of 5 to 7 working days to avoid delay in product delivery from the customs.