Consultant Feedback

"I am impressed with his breadth of Regulatory knowledge and experience, as well as the integrity and quality of his Regulatory work. He emphasizes that Regulatory and Compliance should be data driven and the data need to be integral, traceable, and of high quality."
VP Operations, Biotechnology Company
Overview
  • RegSource Consulting provides a breadth of expertise, providing product development and regulatory consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies.
  • We have worked with the world's leading companies to enhance their long-term competitive advantage, by providing appropriate resources and infrastructure and guiding them through their key product development and regulatory decision milestones.
  • Our Consultants have helped clients lead transformational change, and helped create new organizational models as required, to meet new Regulatory policies or guidelines and change in product development strategies.
  • RegSource Consulting not only provides support for preparation and filing to CDER/CBER/CDRH/EMA and other national and international Agencies, but also provides strategic product development and regulatory and operational planning to all functional disciplines within an organization to achieve successful development timelines.
  • We provide scientific and technological consulting services, including assisting organizations in the research and design, in relation to product development, for pharmaceutical, biotechnology, generic and medical device companies.
  • We provide regulatory and product development support to ensure all processes have been sufficiently designed within the Clinical/Nonclinical and Manufacturing and Commercial functions within an organization to ensure high quality documents are submitted from an organization into regulatory dossiers for either first time filings of major submissions to post marketing activities for approved products.
  • RegSource Consulting also provides product development and regulatory scientific research services to assist with product development for, pharmaceutical, biotechnology, generic pharmaceuticals and medical device organizations.
  • We provide regulatory consulting and design related to the industrial design of manufacturing facilities for pharmaceutical, biotechnology, generic pharmaceuticals and medical device organizations.
  • Regsource Consulting also provides regulatory design and development services for computer hardware and software for compliance related systems.
  • For a more detailed list of the services we provide please view the additional information provided within each service tab listed.