Compliance and Quality Assurance Services

Quality assurance and compliance consultants in the pharmaceutical biotech, and medical device industriesThe Industry Leader in Compliance and Quality Assurance

ProPharma Group provides compliance and quality assurance services that are client tailored and fully aligned with FDA and EMA requirements to the pharmaceutical, medical device, biotechnology, and compounding pharmacy industries.

Our clients know to expect more than just support—with ProPharma Group, they are getting a partner. As our client, you can expect that not only will we work alongside you providing hands-on compliance and quality assurance, but we will provide the strategy and training to help you improve quality systems and mitigate future risks. ProPharma Group works with you to custom tailor a compliance and quality assurance approach according to your needs and goals. Our staff are quick to engage and deliver your customized solution, saving you time and money as you optimize your compliance and quality assurance programs.

ProPharma Group offers the following value-added compliance and quality assurance services:

Compliance:
  • Third-party GMP & GLP Compliance Auditing
  • Mock FDA/International Regulatory Agency Inspections & PAI Readiness
  • Due Diligence Compliance Inspections, Audits & Assistance
  • FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
Quality Assurance:
  • Quality Unit Staff Augmentation
  • Policy, SOP, & Batch Record Review, Creation & Optimization
  • Quality System (QS) Development, Assessment & Optimization
  • Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution
  • Training – FDA, GMP, Regulatory, DQSA, USP <795>, USP <797>, 503b, etc.

More information on ProPharma Group’s compliance and quality assurance services:

Benjamin Frey is the Senior Director of Quality Systems, and is responsible for technical support and Subject Matter Expertise for the company’s Quality Assurance and Regulatory Compliance projects...View full bio