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Services

 With a team of medical experts, Cerneos develops custom product development programs for biotech, medical device, diagnostic and pharmaceutical products. Our services are comprehensive, yet customized, for immediate impact. 

Experience

Cerneos has major client experience from the biotech and pharmaceutical industries, numerous medical startups, and other leading organizations including the American Red Cross, Kimberly Clark Corporation, the National Institutes of Health (NIH) and the Department of Defense (DOD). Our specialties include:

Regulatory Services

  • Regulatory Submissions and documentation for Biologics and drugs (IND, NDA,BLA, eCTD)
  • 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