FDA Regulatory Due Diligence

FDA Regulatory due diligence involves performing an in-depth assessment of the regulatory compliance status of a company and/or its projects. There are a variety of approaches of due diligence but generally involve an extensive review of documentation and evidence to mitigate risk, understand liabilities, and substantiate what is being sold or transferred.

Regulatory problems can be a significant drain on personnel and financial resources when they arise unexpectedly. For this reason, it makes good business sense to conduct regulatory audits and continually practice regulatory due diligence within your company.

Mergers and acquisitions can lead to the discovery of regulatory inconsistencies which can lessen the value of an entire product line or business. Some examples of these inconsistencies would be incomplete or limited product approvals, inadequate complaint-handling systems, inconsistent labelling, or non-compliant manufacturing processes.

Our services in FDA Regulatory Due Diligence include:

• Review of Company organization/ Reporting structure
• Review of status of marketing authorizations/ applications
• Review of complaint log and complaint handling measures
• Review of Adverse reactions log, severity and frequency of reactions and handling measures
• Assess compliance with Regulatory Authorities
• Determine if there is any past, present or pending litigation
• Assessment of Overall cGMP Compliance
• Determine if there are any outstanding commitments or contracts
• Determine apparent and potential conflict of interests
• Conduct GAP analysis

The experienced team of professionals at dicentra can efficiently and thoroughly conduct these regulatory audits and help you employ regulatory due diligence. Our techniques will increase the value of your assets and lessen the business and financial risks associated with unexpected surprises.