Expert Pharmaceutical CMC Analytical Development Consulting Services
Your partner in pharmaceutical method development and validation.
Welcome to Validation Science
Expert Analytical Development
At Validation Science, we provide exceptional analytical development support for pharmaceutical companies. Our expertise in Analytical Development ensures that your projects comply with industry standards and regulations.
CMC Analytical Development Consulting Services
Who We Are
The Founder and CEO of Validation Science, Michael Swartz, is a Ph.D. Analytical Chemist with significant experience in drug development and discovery, business development, marketing, and chromatographic and spectroscopic method development and validation. Michael is a globally recognized leader in analytical chemistry, analytical method development and validation, chromatography, pharmaceutical chemistry, and regulatory compliance. He has consulted for private industry and trade organizations, lectured, and trained worldwide.
Technical Expertise Includes: GMP, CRO/CMO facilitation and management, separation and identification of both small molecule synthetic and biologic pharmaceutical compounds using technology including: High Performance Liquid Chromatography (HPLC) Capillary to Preparative Scale, Ultra Performance Liquid Chromatography (UPLC), Capillary Electrophoresis (CE) and Gas Chromatography (GC), Mass Spectroscopy (MS and MS/MS), Ultraviolet (UV) and Infrared (IR) spectroscopy, Dissolution, Karl Fischer (KF), and Chiral (enantiomer) Assays.
Michael's writing experience includes co-authoring the CMC sections of IND and NDA applications and amendments, books, book chapters, and articles on validation, combinatorial chemistry, and capillary electrochromatography/capillary electrophoresis, over 90 contributed and invited manuscripts, four patents, and over 225 contributed and invited presentations at various technical symposia and conferences around the world.
Michael has served as an expert witness and on the Scientific Editorial Advisory Board of LC/GC Magazine since 1998, as co-author of the popular Validation Viewpoint Column, author of the Innovations in HPLC feature column, and a contributing and freelance writer.
Method Development, Validation and Transfer
At Validation Science, we have decades of experience developing, validating, and transferring GMP analytical testing methods for drug substances and products. From protocol preparation to data review and report generation, we can help streamline the process throughout all phases of drug development, from discovery to commercial.
Technical and Freelance Writing
At Validation Science, our technical and freelance writing services can assist you in preparing everything from peer-reviewed journal articles to marketing brochures. Need a ghost-writer? We can help you prepare that trade journal article, press release, or other promotional communications accurately and efficiently.
Expert Witness Testimony
Law firms, big and small, have used our expert witness consulting services to support litigation in environmental and pharmaceutical/biotech trials. We can explain technical jargon in layman's terms, provide subject matter expert written summaries, and support depositions and trial testimony.
Recruitment and Staffing
Building an Analytical Development Group? At Validation Science, we have recruited and staffed groups from the ground up. Working with a network of over one thousand industry colleagues, we can find the personnel you need to help get your drug to market.
Contact Us
Validation Science
We are located in the greater Boston, MA, area and are always available via email, phone, or Zoom. Feel free to arrange a meeting whenever you are in the Boston, MA, area.
