Regulatory, Standards & Guidance

The pharmaceutical and medical device industries operate in a highly regulated environment where compliance with strict regulatory requirements is crucial for market access, product safety, and business success. Navigating complex global regulations can be challenging, requiring specialized knowledge and strategic planning. QBit QA Consulting provides expert guidance on pharmaceutical and medical device regulatory requirements, helping your organization achieve compliance, minimize risks, and accelerate time-to-market.

Pharmaceutical and medical device companies must comply with a variety of regulations set by international authorities, including the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional regulatory bodies. These requirements cover every aspect of the product lifecycle, from research and development to manufacturing, labeling, distribution, and post-market surveillance.

Regulatory bodies are government authorities that are responsible for and have jurisdiction over the pharmaceutical and medical device industries. They author and maintain administrate law which is legally binding and enforceable. The FDA may criminally prosecute a company or individual for violating regulations, which may lead to fines or imprisonment.

Standards can refer to published standard procedures, processes, monographs or a physical, chemical or biological reference standard. Regulatory bodies may require adherence to ‘standards’.

Guidance for industry may be published by regulatory bodies, agencies or industry societies. Published guidance may also be recognized by regulatory bodies. Regulatory bodies expect that industry adhere to recognized guidance documents.

Regulatory, Standards & Guidance

Food & Drug Administration (FDA)

European Medicines Agency (EMA)

International Standards Organization (ISO)

United States Pharmacopeia (USP)

International Society for Pharmaceutical Engineering (ISPE)

International Council for Harmonization (ICH)

National Institute of Standards and Technology (NIST)