SERVICES
Our services are comprehensive and customized for immediate impact.
Comprehensive & Customized
With a team of medical experts, Cerneos Group develops custom product development programs for biotech, medical device, diagnostic and pharmaceutical products.
Our integrated approach has been successfully used by large and small firms to launch products in the US and overseas.
Regulatory Services
Global Regulatory Strategy and Submissions (CTA, MAA)
Pre- IND and Type A, B, C Meeting development for Biologics and Drugs
Advice on animal model and assay requirements for preclinical studies
Medical Device Regulation (MDR) EU 2017/745 Compliance
In Vitro Diagnostic Regulation (IVDR) EU 2017/746 Compliance
Submissions for Medical Devices ( 510(k),IDE, PMA, DeNovo)
Clinical Trial and CRO Coordination
Product registration – Domestic and International
Strategic and Business Development Solutions
Industry connectors in Life Science, Med-Tech & Biodefense
Strategic partnerships and project management
Soft Landings for innovators worldwide
Venture fundraising resources
Medicare reimbursement planning for products and services
Business market analysis and business planning
NIH, SBA, DoD, and NSF Grant funding and strategic asset development services
Project Management for development and product launch
Resources for global Incubator, Accelerator and TechnologyTransfer programs
Quality System and Compliance Solutions
Quality manuals and quality systems implementation
Quality Suite Development – GXP, GLP, GMP, QSR, ISO 13485, ICH
Internal and Supplier audits (Compliance, CE Mark, CAPA verifications, MDSAP)
MDSAP and Remote Auditing systems for compliance
Validation and Qualification Programs
Process validations (Sterility, Aseptic Processing, Fill/Finish operations)
Cleanroom, HVAC and Temperature Control System Validations
Equipment validation and qualification (IQ, OQ, PQ)
Software validation