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.
Cerneos is working with US Based and international drug, biotech and device firms in oncology, cardiology, infectious diseases and personalized medicine:
- IND, ANDA and BLA submissions for drug and biotech products
- CMC preparation for BLA and NDA projects
- Regulatory submissions management with FDA
- Briefing Book development for Type A, B, C meetings with FDA
- Reviewing Approving product labeling & marketing materials for drug products
Cerneos is working with several international firms on innovative medical device products in the fields of diagnostics, neuromuscular disorders, orthopedics, diagnostics and surgical medicine.
- MDR and IVDR conversion training for medical device firms
- Telehealth and COVID-19 related diagnostics for rapid POC diagnosis.
- Entering devices into the FDA Expedited Access Program (EAP)
- 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
- Developing dossiers, technical files and labeling for devices and combination products
Cerneos projects for US and international firms have covered quality systems, regulatory submissions, software driven devices and biotech products
- Vaccine development and BLAs for infectious disease treatments
- 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