The Polmarc Group specializes in the development of comprehensive quality systems creating an ‘umbrella of quality’ under which your company can meet and exceed the expectations of regulatory agencies.

Whether your organization is at the start of the drug, biologic or device development process or has multiple product lines on the market, The Polmarc Group can work with you to meet compliance standards while getting the most value from your quality systems. The foundation of any quality system is a thorough knowledge of the pertinent regulations. However, without an understanding of the product and the organizational objectives, a poorly designed quality system can encumber the entire process of development.

The cadre of experts at Polmarc work with your management team, scientists, and quality personnel focusing on your product and needs to ensure that the system meets your objectives. Our experts can function as interim QA personnel in any capacity you may require, including writing and review of the full range of QA/QC documentation: Certificates of Analyses (C of As), batch records, analytical and validation master plans, and facility and infrastructure analysis.

Quality Systems support includes:

• Gap Analysis
• Quality Systems Development
• FDA-Style Mock Audits
• Quality Systems Implementation
• Documentation Management Systems
• cGMP Training
• BA/BE Studies
• QA review and sign-off
  
• Quality System Audits
  
• Train-the-Trainer Programs
  
• SOP Writing