Experience

Pharmaceutical Analytical Chemistry, Quality, Compliance and Product Development Expert.  Founder of PharmaAnalytic with extensive experience spanning Quality, Regulatory Compliance and R&D.  As principal consultant, provided regulatory gap assessments, auditing, investigation support, quality remediation, FDA inspection readiness preparation, response assistance, operational support and training.  Additionally, as an individual and a project manager provided product development and research support, methods development and validations for methods, quality release, software, cleaning and processes.  As Director of R&D, built product development groups and successfully created novel FDA approved bioequivalent drug delivery products.  As Director of Quality Control, developed efficient and compliant quality departments successfully completing CMC submissions.  As Principal Scientist, developed hundreds of analytical methods, developed analytical and material characterization groups, along with new technologies – some of which became the basis for the Second USP Research Consortium.  A Research Award recipient, an internationally recognized scientist, speaker and instructor with a proven track record of cutting-edge accomplishments, products, and publications.

Accomplishments

  • Regulatory body inspection readiness – gap analysis, interviewing, coaching, training
  • Quality Remediation – Deviation & Lab Inspection review, coaching, training
  • Successful ANDA submissions & Approval of novel drug delivery products
  • Successful FDA inspection and audit preparation; successful regulatory responses
  • Successful Quality Control Lab remediation from consent decree to ANDA approvals
  • Alcon Research Award for new technology and expedited product development
  • Successful product development within one year, meeting complex bioavailability profiles
  • Created Quality Control programs / groups: raw materials to finished products and stability
  • Designed and developed FDA approved commercial bioequivalent drug delivery products
  • Conducted internal and external regulatory audits in support of quality and development
  • Directed novel pharmaceutical product development from strategy to human clinical trials
  • Created & managed successful Controlled Release Product Research & Development groups
  • Successfully led regulatory compliant instrument qualification and system validation teams
  • Developed, Qualified, Validated hundreds of analytical methods
  • Problem solving resulting in expedited approvals & prevention of unnecessary recalls
  • Internationally recognized expert on Dissolution and Bioavailability & Bioequivalence
  • Authored and maintained departmental analytical, research, quality and regulatory SOPs
  • Authored numerous published scientific articles, including requested articles
  • Invited speaker, conference chair, workshop leader, including USP Research Consortium, National AAPS and joint AAPS / FIP Conferences, Bioavailability / Bioequivalence Conference (Berlin), and joint FIP / Royal Pharmaceutical Society Conference (London)

Previous Clients / Experience (partial)

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