Project Description

Regulatory Advisor

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At Carlsbad Tech® our Regulatory Affairs team ensures the appropriate licensing, labeling and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of our products.
Regulatory Affairs team constantly monitors changing legislation to ensure legal compliance with regulatory agencies. They combine their knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, meet the required legislation. They advise on and coordinate the approval and registration of pharmaceuticals, dietary supplements, OTC medicines, therapeutic devices, cosmetics and other products.

Services Provided:

Regulatory Routine Services

  1. Drug safety and pharmacovigilance
  2. State Licensing and Renewals
  3. Facility and license Registration
  4. Product labeling control
  5. FDA ADE/Annual report filing
  6. Other Reports and Submissions

Regulatory Advisory

  1. Communication with FDA
  2. Initial Establishment Registrations
  3. ANDA Submission Reviews
  4. New ANDA and DMF Submissions
  5. Amendments to ANDA and DMF Submissions
  6. Strategic Advice Throughout Development of New Products
  7. US Agent Services
  8. cGMP compliance and audit

Regulatory Advisory Related Links

  1. FDA Drug Regulator Advisers
  2. FDA Health Supplement Approval Regulatory Advisers
  3. FDA Medical Devices Regulatory Advisers
  4. Over-the-Counter Drug Approval (OTC) Regulatory Advisers

If you require  Regulatory Affairs domestic or international services, please contact Carlsbad Tech®, Click Here

Project Details

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