Team

Diane Reed

Principal Consultant, Regulatory Affairs

Diane has over 20 years of experience in regulated medical products (drugs, medical devices, and combination products) at companies ranging from Fortune 100 companies to startups. Over her career she has supported various types of combination products including prefilled syringes, IV-bags, nasal sprays, and co-packaged products. Other experience includes electromechanical, laser ablation, and spinal implant devices, in addition to small molecule CMC and product lifecycle management. Diane prioritizes quality and delivering exceptional products by listening, mentoring, and collaborating with her team.

Academic & Professional Qualifications:
  • B.S. Chemistry, Colorado School of Mines
Training, Quality Systems, & Specialties:
  • Regulatory Affairs/Submissions/Strategy
  • ISO 13485
  • ISO 14971
  • IEC 60601
  • 21 CFR Part 4
  • 21 CFR 820
  • 21 CFR 210 and 211
  • CMC Drug Product
  • Product Lifecycle Management
  • DHF Remediation
  • Warning Letter Remediation