GxP GAP Assessment Audits: Strengthening Compliance Across the Entire Quality Spectrum
The Pharmaceutical, Biotechnology, and Life Sciences industries have experienced a rapid acceleration in their evolving regulatory expectations. Organizations within these sectors have a duty to remain compliant with Good Manufacturing Practices (GMP) as well as the complete range of GxPs: from Good Laboratory Practice to Good Distribution Practices, from Good Clinical Practices to Good Documentation Practices.
Regulatory Submissions Management: Driving Compliance and Speed in Global Markets
These days, rules around the world keep getting stricter. If you’re trying to launch a new drug, medical device, or even a cosmetic, you can’t afford to mess up your regulatory submissions management process. Getting these submissions right quickly and by the book makes all the difference.
Good Clinical Practice (GCP) Audits: Ensuring Quality and Integrity in Clinical Research
Clinical research never slows down, and the stakes are high. You can’t cut corners on quality, safety, or ethics—not even for a second. That’s why Good Clinical Practice, or GCP, exists.
The Role of GMP Internal Audits in Ensuring Quality Excellence
Staying compliant with Good Manufacturing Practice (GMP) standards is essential for pharmaceutical and life-science organizations to ensure product quality, protect patient safety, and follow regulations.
GMP Vendor Audits: Strengthening Supply Chain Quality and Compliance
In the pharmaceutical and life sciences sector, the quality of your end product is closely tied to the reliability of your suppliers. As global supply chains grow more intricate, regulatory bodies like the FDA, EMA, MHRA, and WHO are raising their expectations for companies to show strong oversight of their vendors.