Projects

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Cerneos is ideally suited for companies developing biomedical products for global and domestic markets.  We develop and implement regulatory strategies, manage projects and prepare submissions for biologic, medical device and drug submissions.  Our integrated approach has been successfully used by large and small firms to launch products in the US and overseas.

Active Projects:

Cerneos is working with US Based and international pharmaceutical and device firms in oncology, cardiology, infectious diseases and personalized medicine:

  • Preparing global regulatory strategies
  • Coordinating regulatory filings with the FDA
  • Coordinating with Clinical, CMC, technical, and development teams
  • Submitting IND, ANDA and BLA submissions
  • Reviewing and approving product labeling and marketing materials

 

Cerneos is working with several international firms on innovative medical device products in the fields of diagnostics, neuromuscular disorders, orthopedics, diagnostics and surgical medicine.

  • Preparing US and international regulatory and product development strategies
  • Obtaining 510(k) and DeNovo clearances for innovative devices
  • Obtaining CE Mark for medical devices and ISO certification for device firms
  • Finding new applications for patient and clinician uses for device and combination products
  • Coordinating US and international strategy for product registration and launch
  • Gaining acceptance for device products into the FDA Expedited Access Program (EAP)
  • Developing dossiers, technical files and labeling for devices and combination products

 

Past Projects:

Cerneos projects for US and international firms have covered quality systems, regulatory submissions, software driven devices and biotech products

  • Established quality manuals and standard operating procedures (SOPs) for quality systems
  • Conducted FDA and ISO 13485 inspections and obtained certifications for device firms
  • Reviewed third-party software information and firms on software documentation and validation
  • Conducted in-depth quality audits of critical processes and documentation and made improvement recommendations
  • Prepared medical device components firms for CE Mark Certification
  • Obtained certifications for firms selling to international medical device firms

 

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