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Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Joshi, Priti, MS
Certifications PMP
Education
  • Graduate Research Fellow, Macromolecular Science and Engineering - University of Michigan, Ann Arbor
  • Master in Technology, Polymer Science - Indian Institute of Technology (IIT), New Delhi, India
  • M.S. Chemistry - Indian Institute of Technology (IIT), New Delhi, India
  • B.S. Chemistry - Hindu College, Delhi University, New Delhi, India
Business Address PO Box 4609
Mountain View, CA 94040
Contact information
Telephone:
Fax:
Mobile Number:
Email address:
408.219.5759
650.947.0975
408.219.5759
priti_joshi@yahoo.com
Specialties

Regulatory Affairs, Quality Assurance, Project and Portfolio Management for drugs, medical devices, diagnostics and combination products.

RAC and PMP certified.

  • Regulatory
    • Life-cycle management strategies for devices, diagnostics and combination products
    • Filing requirements for medical devices: IDE, 510(k), PMA, Tech Files, Design Dossiers
    • Non-clinical and clinical readiness requirements for novel products and excipients
    • Post-submission responses to agency questions, deficiency or clinical hold letters
    • Post-approval product change justifications and supporting regulatory documentation
  • Quality / Compliance
    • FDA and Notified Body inspection experience; ISO 13485 Lead Assessor Training
    • Responses to FDA 483, Warning Letters and Notified Body audits
    • Quality System implementation for drugs, devices, and combination products
    • Design Control, Risk Management (ISO 14971), CAPA
    • Supplier control and monitoring, supplier auditing, reporting, and follow up activities
    • Post-approval Changes, Post-market Surveillance systems, Adverse Event Reporting
  • Project Management
    • Expertise in integrating Microsoft Project plans with drug/device regulatory filing requirements
    • Project management for drugs and devices using Target Product Profiles (TPP) and Stage-Gates
    • Product risk management, planning, sourcing, budgeting, tracking deliverables and milestones
    • Alliance management of global contract manufacturers and vendors (CMC, nonclinical, clinical)
    • Technology transfer, scale-up and commercialization planning
    • Project Management of cross-functional global and virtual teams
    • Regulatory project management
Experience

 

 

Diverse experience in R&D, regulatory, quality, and project management of drug delivery systems, medical devices, diagnostics and combination products.  Managed products through research and development, technology transfer, scale-up, commercialization and post-commercialization.  Expertise in managing global internal and external cross-functional teams.  Well versed in life cycle management, regulatory, clinical, and IP strategies.  Advanced multi-disciplinary academic training in project management, materials science, polymer science, and pharmaceutics.  


  • Since Oct 07: Independent Consultant
  • Jul 07 – Dec 07: FibroGen Inc., Director, Collagen Program Development
  • Oct 05 – Apr 07: Corium International Inc., Project Manager, R&D
  • Apr 02 – Sep 05: HemoSense Inc. (now Inverness Medical), Manager, Regulatory / Quality Assurance
  • Jun 94 - Jun 99: Cygnus Inc., (now J&J), Staff Scientist, New Product Feasibility
  • Jul 92 - Jun 94: Matrix Pharmaceuticals (now Novartis), Research Associate, Drug Delivery Research
  • Feb 91 - Jul 92: SmithKline Diagnostics (Division of Beckman Coulter), Associate Scientist, Product Development
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