Who we are

A unique team of consultants offering authentic expertise and unparalleled global reach.

 

Tara M. Creaven-Capasso, MAppSc., RAC, RQAP-GLP

With over 24 years experience working in the US and Europe, Tara Creaven-Capasso, RAC, RQAP-GLP specializes in providing Regulatory Affairs, Quality Assurance and Compliance services to the Biotechnology, Pharmaceutical and Medical Device sectors. Experiences include but are not limited to: product development leading to 50+ product approvals, regulatory strategy development; regulatory submission preparation; quality system establishment; GXP compliance; successful FDA inspections (including preparation and gap analysis), evaluation and risk assessment of products; non-clinical and clinical research protocol design and development; evaluation of field complaints and medical device reporting; quality, regulatory and clinical system compliance support including expedited programs, particularly in the FDA environment, or combinations of the above, from late discovery through late clinical trial and approval phases.

Tara actively participates in industry groups and meetings such as the Regulatory Affairs Professionals Society (RAPS), Society of Quality Assurance (SQA) and the Society of Public Responsibility in Medicine and Research (PRIM&R). She is also an Invited speaker at national and international venues as well as an invited educator to industry and academic institutions on topics relating to regulatory affairs, regulatory sciences, quality and compliance with respect to US FDA and international regulations.

 

 

Areas of Expertise

  • Product development
  • Regulatory strategy development
  • Regulatory submission preparation
  • Quality system establishment
  • GXP compliance
  • Regulatory body¬†inspections
  • Evaluation and risk assessment of products
  • Non-clinical and clinical research protocol design and development
  • Evaluation of field complaints and medical device reporting
  • Quality, regulatory and clinical system compliance