Venture Capital Due Diligence Consulting and Audits

  • Perform GMP/GLP/GCP audits of facilities worldwide to assess regulatory (i.e.: FDA, DEA,    OSHA, EU, MHRA, TGA, etc.) compliance
    • Following the audits, provide a detailed gap analysis of deficiencies
    • From the gap analysis, develop a plan with estimated timeline and cost for preventive and corrective actions (CAPA)
  • Evaluate technology in areas of drug delivery, medical devices, and diagnostics
  • Assess capabilities of company resources including management, development plans, clinical and regulatory strategy
  • Provide recommendations to bolster facilities, staff, and/or provide services to keep pace within the industry
  • Evaluate Contract Manufacturing Organizations (CMOs) hired by companies
  • Provide strategic advice on regulatory matters from filings to evaluation and resolution of complex scientific and regulatory issues
  • Survey prospective company's clients (past and present) for their opinion of the company's strengths and weaknesses, and prepare an evaluation of findings
  • Suggest expansion of facilities, staff, and services (if needed), to keep pace with the industry best practices and competitors
  • Evaluate the competency of the company's personnel, both for their ability to perform their duties, as well as how they compare to their counterparts in similar companies
  • Perform an in-depth post-acquisition GMP/GLP/GCP audit, with gap analysis and development plan
 

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6 Jacobs Lane
Scotch Plains, New Jersey 07076