Who We Are

BioProcess Technology Consultants is the leader in providing strategic, technical, and regulatory consulting services for the manufacture, quality control, and quality assurance of biopharmaceutical products. BPTC understands first-hand the challenges of developing and commercializing new products and technologies. We provide customized consulting services for the design and implementation of effective product development and commercialization programs, helping our clients meet the specific requirements of their products, ensure proper regulatory compliance, and accelerate the path from clone to commercial®.

Contact us to learn how we can:

  • Enhance your overall corporate value through the design and implementation of phase-appropriate product development and manufacturing programs
  • Provide powerful decision-making tools to support your development and commercialization requirements and help you meet key business milestones
  • Help you advance your products from clone to clinic® faster and more efficiently while minimizing risk and expense
  • Improve the efficiency of your CMC and supply chain activities by aligning them with your strategic and tactical objectives
  • Support the development of cost-effective, reproducible manufacturing processes and appropriate quality control methods and specifications
  • Ensure your regulatory compliance through the preparation and review of quality systems, GMP training, compliance audits, pre‐approval inspection preparation
  • Develop global CMC regulatory strategies, prepare phase-appropriate regulatory submissions, and organize and participate in meetings with regulatory agencies
  • Evaluate manufacturing data and strategies for in-licensing or investment opportunities with candid and in-depth assessments of status and timelines

History

Since 1994, BPTC has been providing cutting-edge, solution-oriented consulting services. Starting with a single visionary and experienced consultant, the Company today employs a team of accomplished professionals with significant biopharmaceutical industry experience and a broad range of expertise. Our staff includes founders and early employees of several successful start-up biotechnology companies as well as former executives from large biotechnology and pharmaceutical companies. In addition to our staff of full time consultants, the Company has exclusive subcontracting arrangements with specialized subject matter experts who provide additional consulting services to our clients on an as needed basis. With the opening of BPTC Europe in September 2010, the Company now employs full-time consultants and subcontractors based on the east and west coasts of the United States, Canada, Europe, and Asia, enabling us to provide expert development, manufacturing, quality, and regulatory consulting services and support worldwide.