Import and Product Registration For Medical Device:

Operon strategist can  assist Medical Devices , Foods , Cosmetics companies for  registration and licensing .In Case your company is large or small , domestic or foreign, we have the ability to  direction your regulative needs.

FDA Regulatory Consulting ,Submission and Auditing Services:

The operon strategist consists of proficient who know what FDA and other regulatory bodies desire of pharmaceuticals, medical devices, foods, cosmetics, dietary supplements and other managed products provide for sale in the United States or other countries throughout the world.

Operon strategist offers a range of Medical Device consulting, submission and   auditing services including:

  • Preparation and submission of 510(k) pre-market notification to FDA approval.
  • Conducting quality system audits of medical device manufacturers.
  • Assistant medical device manufacturers for implement quality control/assurance, regulatory affairs, Handling compliant, document.

Operon strategist provides the following services for FDA Registration :

  • Import Registration of Drugs.
  • Medical device manufacturing site Registration.
  • New Product License for manufacturing in India.
  • Cosmetic registration for import in india.
  • Medical Device Registration Consulting.

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