GxP (GLP, GCP and GMP) biopharmaceutical and medical device product compliance

There's nothing more harmful to a company than having a product pulled off the market or getting a delay on a high profile approval.

Strategic GxP (GLP, GCP, GMP) biopharmaceutical and medical device compliance

Our trusted experts, including renowned former regulators, know how to institute proactive compliance and have a strong track record of helping companies get out of regulatory crises. They are well versed in biopharmaceutical, medical device / diagnostic regulations and ICH guidance, and are focused on the success of your products and company.

Biopharmaceutical and medical device product consultants - PAREXEL Consulting has biopharmaceutical medical device product compliance (as well as cosmeceutical and neutraceutical product types) solutions for small and large companies alike, from global audits to loaned executives, ad-hoc advice or inspection readiness training. We help companies manage risk effectively in global markets to protect and grow product and company reputation and value.

Key biopharmaceutical and medical device compliance offerings:

• GLP, GCP and GMP Compliance Strategies
• GLP, GCP and GMP Audits & Assistance
• PAI and Regulatory Audit Inspection Readiness Training
• Third Party or Supplier Audits and Assessments
• Quality and Compliance Governance Assessments and Loaned Executives
• Due Diligence of Potential Product and Facility Acquisitions
• Assistance during inspections and with post-inspection correspondence and meetings
• Assistance to legal counsel in FDA enforcement matters
• PET (Positron Emitting Tomography) compliance services to meet FDA Regulations Going into Effect December 12, 2011

Biopharmaceutical and medical device product compliance value proposition

When you invest in proactive pharmaceutical quality and compliance to keep your product on the market, you're avoiding the pitfalls and risks of product failure in one or multiple markets. Setbacks that come with this scenario can include delay of approval, product recalls, harm to reputation, as well as adverse impact on shareholder value. Litigation is costly, too, not to mention loss of capital for other products.

If you are already in a regulatory warning or crisis situation, having trusted experts to help you respond quickly and effectively is critical to minimizing damage and preserving value.

Current FDA 483 policy:

Reminder: The FDA has policy concerning written responses to FDA-483 observations gives companies 15 days to respond in writing to the FDA after a 483 is issued, if they wish their comments to be taken into consideration when the FDA is deciding whether or not to issue a warning letter. Read More

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