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.
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
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.