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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Lang, Johanna, PhD
Business Name Lang Consulting, Inc.
Certifications
Education

PhD Chemistry, University of Graz, Austria

2 years of postdoctoral training at University of California, Berkeley

Business Address 4219 Tanager Terrace
Fremont, CA 94555
USA
Contact information
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Specialties

Design and execution of strategies for product manufacturing, quality control, product stability assessments and validation studies

Planning, execution and documentation of assay (test method) development and manufacturing process validation studies (ICH guidelines)

Design/review of manufacturing documents, test methods and other GMP documentation

Design/review of bioanalytical methods and cell based assays, incl. method validation (GLP documentation)

Preparation of regulatory submissions (IND, NDA/BLA, MAA), in CTD and e-CTD formats

Managing technology transfer, GMP manufacturing and QC testing by contract manufacturers/laboratories, directing R&D projects/ teams.

Experience

 Lang Consulting, Inc., Fremont, CA  since 1999 CMC Consultant: Strategic and scientific/technical product development consulting services to the Biomedical Industry. Works with clients to develop and implement strategies for API and drug product manufacturing and testing in compliance with FDA and EMEA regulations.  

IDEA GmbH, Muenchen, Germany  1997-1998 Director, Product Development: Responsible for all product development activities in startup company developing transdermal small molecule, peptide and protein delivery systems. 

 Pharmacyclics, Inc., Sunnyvale, CA 1993 -1996 Director of Analytical and Pharmaceutical Sciences: Established and directed Analytical and Formulation Development functions for new chemical entities for oncology and cardiovascular therapies. 

 Liposome Technology, Inc., Menlo Park, CA  1987-1990 Senior Scientist: Established Analytical Development capabilities at startup company. Directed development, validation and implementation of release/stability assay, in-process assays and bioanalytical assays.

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