Regulatory Compliance Services

We have extensive experience offering regulatory compliance services, which include performing audits, qualifications, validation, and document management. Some examples of our previous engagements are:

Our previous engagements have included:

  • Quality Assurance review and analysis of project documentation deliverables
  • Regulatory Compliance and Risk Assessments, including for SOX, GMP, GLP, GCP, PDMA, 21 CFR Part 11
  • Independent internal and external vendor audits, both IT and GxP
  • Development of Standardized Regulatory Practices and Processes leading to reductions in the "validation life cycle"
  • Independent pre-audit inspections and reviews
  • Facility Qualifications - Manufacturing sites as well as IT Data Centers
  • Establishment of Quality Management Systems

We have built a reputation of employing high quality personnel who have extensive industry experience within several regulated markets. For each engagement, our consultants leverage their knowledge and expertise to support the improvement of quality and to mitigate the regulatory risk, while reducing the tendency for redundant and excessive efforts.

Our services go beyond compliance with the current regulations. We anticipate future regulatory changes and strategies and engage our business network, which includes the FDA, and industry thought leaders.