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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Shadle, Paula, BS, PhD
Business Name Shadle Consulting Services
Certifications
Education

Ph.D. in biochemistry at university of California San Diego; BSc. in Zoology

Two years postdoctoral fellowship at Max Planck Institute for Biophysical Chemistry, Germany

Business Address 501 McBride Drive
Lafayette, CA 94549
USA
Contact information
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Specialties

Biopharmaceuticals:  Process development and validation, analytical methods development; CMC strategy, quality assurance, technology transfer, quality agreements, CMO collaborations, QA audits, GMP training.   We help position you for licensure by building in the quality during development and anticipating hurdles.  We excel at troubleshooting and assuring that exceptions are investigated and documented with good science and an eye towards proper compliance.

Experience

Shadle Consulting, founded in 2001, has supported clients with process validation strategy, post-licensure site changes, comparability protocols, and in-sourcing QC methods during late phase product development.  We offer GMP training and team building, liaison with contract manufacturers and laboratories; inspection preparedness, supplier audits, and more.  Visit our website at www.biopharmpro.com for more information.  Our combination of in-lab experience and quality unit/ strategic planning is unique.  We can help you to get the most out of your cross-functional team.

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