Welcome

QualPharm is your alternative to conventional consulting.  QualPharm is a network of independent consultants specializing in CGMPs for the pharmaceutical industry. As a consortium of experts, QualPharm has minimal overhead and marketing costs so your company gets the highest level of talent at rates that many low-end consultancies charge for entry level talent.

QualPharm provides pharmaceutical/biotechnological/compounding experience in Quality Assurance, Quality Control, Technology Transfer, Validation, Operations and Business Analytics focusing on the following:

  • Regulatory compliance with US and international GMPs
  • Inspection readiness and preparation
  • Regulatory action response and remediation
  • Quality System design, implementation and continuous improvement
  • Aseptic manufacturing and sterility assurance
  • Investigation and CAPA review and system improvement
  • Process control and statistical analysis
  • Product commercialization and technology transfer
  • Process and analytical validation oversight
  • Quality Control laboratory controls/Data integrity
  • Combined Quality and Business Analytics
  • Third Party Manufacturer and Supplier/Vendor compliance audits
QualPharm consultants generally have 20+ years of experience in the industry (most exceed 25-30 years) and most have held director or higher level positions across numerous pharmaceutical companies. Our pool of consultants include professionals who have held senior level Quality positions with Hospira, Amgen, Sandoz, Baxter, Novartis, etc. This affords us the opportunity to assist your firm at any stage of growth. Likewise, QualPharm consultants can serve in an interim Quality/Compliance management role, ensuring critical leadership in the midst of filling key senior management positions.
QualPharm can help your company whether you are a start-up/virtual company building your quality system or an established, mid-level pharmaceutical manufacturer with compliance improvement goals or remediation concerns. Today’s regulatory environment requires companies to be at the top of their game and QualPharm is well positioned to provide expert assistance to that end.

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