We help you develop and maintain a robust quality management system (QMS) that meets the requirements of ISO 9001, ISO 13485, GMP, GVP, and IVDR/MDR.
We also offer a range of audit services, including:
Our GMP audits are conducted by a team of experienced professionals who are experts in the pharmaceutical industry. We will assess your manufacturing processes against the GMP regulations, and identify any areas for improvement. We will also provide you with recommendations on how to correct any deficiencies.
Our GMP audits can help you to:
We conduct GVP audits to ensure that your pharmacovigilance system meets the requirements of Good Pharmacovigilance Practices (GVP). GVP is a set of regulations that govern the pharmacovigilance of medicinal products. It ensures that pharmacovigilance systems are in place to identify, assess, and manage risks associated with medicinal products.
Our GVP audits are conducted by a team of experienced professionals who are experts in the pharmaceutical industry. We will assess your pharmacovigilance system against the GVP regulations, and identify any areas for improvement. We will also provide you with recommendations on how to correct any deficiencies.
Our GVP audits can help you to:
We help you prepare for and manage regulatory inspections, whether they are conducted by local or international authorities. We work with you to understand the inspection requirements, identify any areas of non-compliance, and develop a corrective action plan. We also provide training to your staff on how to respond to inspectors’ questions and concerns.
Our inspection preparation and management services include: