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Cerneos is ideally suited for companies who wish to develop integrated project teams for an international biomedical company, managing regulatory submissions, software controls and lab facilities development for a firm that wishes to launch a product in the US or a US firm that wishes to launch overseas.

Active Projects:

Cerneos is working with a US Based firm on a pharmaceutical product in oncology

  • We are preparing US regulatory strategy
  • Coordinating filings with the FDA
  • Coordinating with Clinical, CMC, technical and development teams
  • Preparing Device products for Expedited Access Program
  • Preparing technical files and certifications for orthopedic, ophthalmic and diagnostic products

Cerneos is working with several international firms on innovative medical device products

  • We are preparing US and international regulatory and product development strategies
  • Finding new applications for patient and clinician uses
  • Coordinating US and international strategy for product launch

Past Projects:

Cerneos worked with a US firm to:

  • Establish a quality manual and standard operating procedures for a quality system sufficient to stand up to FDA inspection, and to support ISO 13485 certification;
  • Review software validation documents for the clinical decision support product, and advising on necessary improvements;
  • Review information about the third-party software that the client is offering,  and advising on how to document and validate that software.
  • Conduct an in-depth quality audit of inhouse processes, and report on where improvements are needed.