GCP & GMP Strategic 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.
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Strategic 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 regulations and ICH guidance, and are focused on the success of your product and company.
Pharmaceutical consultants - PAREXEL Consulting has compliance 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 Offerings:
- GCP and GMP Strategy
- 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
Value Proposition:
When you invest in proactive 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.
New FDA Policy :
The FDA has established a new policy concerning written responses to FDA-483 observations. The policy 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
Key Contact:
Please contact David L. Chesney, Vice President, Strategic Compliance, PAREXEL Consulting if you are interested in an executive briefing on Strategic Compliance.
