Cerneos
Cerneos Group is a deeply experienced consulting firm specializing in bringing life sciences products to market efficiently. They offer comprehensive services in regulatory, scientific, engineering, and business development, working with international health authorities and providing tailored solutions for biotech, medical device, diagnostic, and pharmaceutical companies. Their mission is to shorten drug and device development timelines through global regulatory strategy, clinical trial coordination, scientific research, and business support, including strategic partnerships and global supply chain support.
Industries
Nr. of Employees
small (1-50)
Cerneos
Newton, Massachusetts, United States, North America
Products
Thoughts for Developing Software Quality Procedures (whitepaper)
Whitepaper addressing software quality assurance and considerations for validating off-the-shelf software in regulated environments.
Corporate capability deck (PDF)
Corporate presentation describing integrated consulting capabilities across regulatory, scientific, and business services.
Thoughts for Developing Software Quality Procedures (whitepaper)
Whitepaper addressing software quality assurance and considerations for validating off-the-shelf software in regulated environments.
Corporate capability deck (PDF)
Corporate presentation describing integrated consulting capabilities across regulatory, scientific, and business services.
Services
Consulting on global regulatory strategy and preparation of regulatory submissions for drugs, biologics, devices, and diagnostics, plus meeting preparation for regulatory interactions.
Coordination of clinical trials and management of CRO relationships to support study execution and regulatory reporting.
Feasibility studies, preclinical safety evaluations, assay and microfluidic test development, and CMC technical documentation to support design, patent, and regulatory submissions.
Design and implementation of quality manuals and QMS, internal and supplier audits, CAPA verification, ISO 13485 and other certifications, and MDSAP/remote auditing capability.
Process validations, cleanroom/HVAC/temperature control validations, equipment IQ/OQ/PQ, and software validation programs for regulated manufacturing and laboratory environments.
Market analysis, payer and reimbursement planning, pricing strategy, and pre-launch planning to support market entry and commercialization.
Consulting on global regulatory strategy and preparation of regulatory submissions for drugs, biologics, devices, and diagnostics, plus meeting preparation for regulatory interactions.
Coordination of clinical trials and management of CRO relationships to support study execution and regulatory reporting.
Feasibility studies, preclinical safety evaluations, assay and microfluidic test development, and CMC technical documentation to support design, patent, and regulatory submissions.
Design and implementation of quality manuals and QMS, internal and supplier audits, CAPA verification, ISO 13485 and other certifications, and MDSAP/remote auditing capability.
Process validations, cleanroom/HVAC/temperature control validations, equipment IQ/OQ/PQ, and software validation programs for regulated manufacturing and laboratory environments.
Market analysis, payer and reimbursement planning, pricing strategy, and pre-launch planning to support market entry and commercialization.
Expertise Areas
- Regulatory compliance and submissions
- Clinical trial management and CRO coordination
- CMC and analytical/chemical development
- Quality systems and GxP compliance
Key Technologies
- Microfluidic assay development
- Telemedicine/home exam platforms
- Electronic regulatory submissions (eCTD)
- CMC documentation and analytical method development