Biologics

Biological products are medical products derived from living organisms. Such products are regulated under the Public Health Service Act as well as under various provisions of the FDCA. Legally, biological products are defined as including a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or  its derivatives (or any other trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings.

To be lawfully marketed in interstate commerce, a biological product must be the subject of a biological license, issued by FDA on the basis of a demonstration that the product is safe, pure, and potent, and that the facility in which the product is manufactured meets standards to assure that it continues to be safe, pure, and potent. CCS offers a range of biologics consulting, submission and auditing services including:


  • Conducting cGMP, Quality Systems and Pre-Approval Audits
  • FDA Regulatory Correspondence and Responses ∇
    • FDA 483 Responses
    • Warning Letters
    • Untitled Letters
    • Consent Decrees
  • Interpreting FDA policy, guidance and procedures
  • Regulatory Submissions ∇
    • IND
    • BLA
    • CMC
  • Developing Corrective Action Plans (CAPA)
  • 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
    • Institutional Review Boards (IRBs)
    • Sponsor Monitor
    • Clinical Investigators
  • Registration & Listing
  • Validation ∇
    • Process
    • Software
    • Equipment
  • U.S. Agent Services
  • Representation at regulatory meetings with FDA
  • Seminars & Training






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