Quality Assurance and Compliance

Quality and compliance add value to any organization and ensure the safety of medicines.  For small companies, staying abreast of the changing regulatory landscape and understanding current compliance standards can be overwhelming.   Additionally, with the industry trend to out-source work to Asia, the need to monitor compliance is increasing as there is inherently less control due to larger distances.  CapEval Pharma consultants can give you peace of mind and help assure the regulatory compliance and quality of your medicinal products, tests, and studies.   

We bring specific expertise in the following areas:

•  Development of policies, work instructions and specifications to meet GMP requirements, including the latest FDA, Pharmacopeia and EMA guideline

•   Preparation of quality agreements

• Review and approval of change control, deviations, corrective/preventative actions and out-of-specification documentation

• Preparation and review of GMP documentation, including master production records, batch records, testing records, stability protocols and reports, development reports, and SOPs

• Assure GMP compliance of API manufacture for clinical or commercial material

• Preparation and review of validation protocols and reports

•  Work with in-house QA to improve existing quality systems

• GMP, IPEC, and ISO audits

  • API and drug product manufacturers

  • Testing laboratories

  • Excipient and raw material suppliers

  •  General quality systems audits, audit for cause or lot specific audits

  • Audits of contract facilities for supplier selection or GMP compliance