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:

Strategic and Business Development Solutions

  • Scientific and Engineering review and validation services
  • Referrals to Incubator, Accelerator, Technology Transfer and venture funding services
  • Product Development and Scale-Up Programs
  • Grant funding and strategic asset development services
  • Translational Medicine and Technology Programs
  • Financial network development and reimbursement resources
  • Venture fundraising and grant development resources
  • Project Management for development and product launch
  • AI and IT based solutions for diagnostics and early detection
  • MDR and IVDR training and conversion planning for global device firms
  • US Agent Representation – for foreign clients
  • Strategic sourcing and supply chain development
  • Validation and process engineering services

Regulatory Services

  • Global Regulatory Strategy
  • MDR/IVDR compliance, training and compliance
  • Regulatory Submissions and documentation   (IND, NDA,BLA, eCTD, 510(k),IDE, PMA)
  • Clinical Trial and CRO Coordination
  • Vaccine and Biotech product development
  • CE Mark and International registrations
  • Design Control and Development
  • Product registration – Domestic and International
  • Risk Management and evaluation
  • FDA and Notified Body Liaison
  • Usability and Human Factors

Medical Devices

  • FDA GXP compliance services
  • Medical Device Regulation (MDR) EU 2017/745 Compliance and Training Programs
  • In Vitro Diagnostic Regulation (IVDR) EU 2017/746 Compliance and Training Programs
  • CE Mark and International regulatory services
  • International product registrations
  • ISO 9001, 13485 and 14971, MDR and IVDR compliance
  • Quality systems development and training
  • Design dossier and technical file development
  • Project management services

 

Pharmaceuticals, Vaccines and Biologics

  • IND, BLA, NDA, ANDA global strategy preparation and project management
  • Vaccine and Therapeutic CMC preparation, editing and project management
  • Pre- IND and Type A, B, C Meeting development
  • IND/BLA development
  • Process development and validation service
  • Drug establishment registrations

Quality System and Compliance Solutions

  • Quality manuals and quality systems implementation
  • Quality Suite Development –   GXP, GLP, GMP, QSR, ISO 13485, ICH
  • Liaison to the FDA (Meeting preparation, submissions and FDA response)
  • Liaison to International Notified Bodies
  • Compliance training programs (ISO, GXP, GCP, MDR, IVDR)
  • Internal and Supplier audits (Compliance, CE Mark, CAPA verifications, MDSAP)
  • Supply Chain Management
  • MDSAP and Remote Auditing systems for compliance
  • CE Mark compliance development
  • Corrective Action/Preventive Action (CAPA)
  • Dodd-Frank: Conflict Free Metals

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
  • Validation and Commissioning protocol and upgrade programs
  • Validation and Commissioning of facilities and equipment

 

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