The statutory definition of a drug emphasizes the fact that they are: 1) articles “intended” for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; 2) articles recognized in the U.S. Pharmacopeia, the U. S. Homeopathic Pharmacopeia, or the National Formulary; 3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and 4) articles intended for use as a component of any of the above.  It is the intended use which determines whether an article is a drug and is subject to the drug requirements of the law if therapeutic claims are made on them.

Before a drug or new drug may be marketed, it must be approved by FDA. The world of FDA drug approval can be divided into six basic categories: new drugs, abbreviated new drugs, over-the-counter (OTC), new animal drugs, abbreviated new animal drugs, and biologics. There is not one single FDA approval process that applies to all drugs, but a set of processes, each applying to different kinds of products with important elements in common, but also some key differences. CCS offers a range of pharmaceutical consulting, submission and auditing services including:

  • cGMP, Quality Systems, GAP and Pre-Approval Audits
  • FDA Inspection Readiness and Response ∇
    • FDA 483 Responses
    • Warning Letters
    • Untitled Letters
    • Consent Decrees
  • Interpreting FDA policy, guidance and procedures
  • Regulatory Submissions ∇
    • INDs
    • NDAs
    • ANDAs
    • CMC
    • ADEs
  • Laboratory compliance with cGMP and applicable requirements
  • Developing Corrective Action Plans
  • Product Recall policies and procedures advice and assistance

  • Preparing product/process SOPs
  • Import and Export guidance
  • Product labeling review
  • Advertising and Promotion
  • Bioresearch Monitoring ∇
    • Clinical Trials
    • Sponsor Monitoring
    • Institutional Review Boards
    • Human Subject Protection
  • Drug Registration & Listing
  • Validation ∇
    • Process
    • Software
    • Equipment
  • U.S. Agent Services
  • Seminars & Training

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