Over the last decade, there have been significant changes in the legislation governing the development of pharmaceutical and biologic products—many of these aimed at improving patient safety. A number of these changes have focused on developing, more quickly, a better understanding of the benefits versus the risks of prescribing medicine to individual patients, post-approval. This…Details
Unbiased and systematic audits are essential components of any pharmaceutical company’s Quality Management System (QMS). EuroPharm Consulting offers a range of external Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), Good Manufacturing/Distribution Practices (GMP/GDP) and business due diligence audits. We have completed hundreds of successful on-site and remote audits, monitoring global systems/processes and local affiliates; external licensing partners, vendors and investigator sites to ensure their compliance with internal procedures and regulatory requirements.