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Answer: The regulatory requirements vary by region. In the U.S., drugs must go through the FDA’s approval process, which includes preclinical testing, clinical trials (Phase I, II, III), and submission of a New Drug Application (NDA) or Biologics License Application (BLA). In the EU, the process is managed by the EMA. Regulatory hurdles typically include proving the safety, efficacy, and quality of the product.

Answer: Data integrity is crucial in all GxP areas (GMP, GLP, GCP). Consultants recommend adopting the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) for data management. This includes validating computerized systems, ensuring audit trails, and implementing strict document control processes.

Managing audits, especially in highly regulated industries like pharmaceuticals, requires thorough preparation, effective communication, and a systematic approach. Whether the audit is internal or external (e.g., by regulatory authorities like the FDA, EMA, or MHRA), the goal is to demonstrate compliance with applicable standards (GxP, ISO, etc.) while identifying areas for improvement.