Services

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

Strategic and Development Solutions

  • Global Regulatory Strategy
  • Product Development and Scale-Up Programs
  • GAP Analysis and Compliance services
  • US Agent Representation – for foreign clients
  • Staff Augmentation
  • Strategic sourcing and supply chain
  • Project Management
  • Validation and process engineering services

Regulatory Services

  • Regulatory Submissions and documentation  (IND, NDA,BLA, eCTD, 510(k),IDE, PMA) 
  • 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

Quality System and Compliance Solutions

  • Quality Suite Development – GMP, QSR, ISO 13485, ICH
  • Quality Systems implementation
  • Quality systems documentation
  • Internal and Supplier audits
  • Supply Chain Management
  • CAPA Management and Compliance
  • Equipment Validation and Qualification

Experience

Cerneos has major client experience from the medical device, 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:

Medical Devices

  • FDA GXP compliance services
  • CE Mark and International regulatory services
  • International product registrations
  • ISO 9001, 13485 and 14971 compliance
  • Quality systems development and training
  • Design dossier and technical file development
  • Project management services

Strategy and Development

  • Global regulatory strategy 
  • Product development and scale-up programs
  • GAP analysis and compliance services
  • U.S. agent representation – for foreign clients
  • Staff augmentation
  • Strategic sourcing and supply chain
  • Project management
  • Validation and process engineering services

Pharmaceuticals Vaccines and Biologics

  • Vaccine and Therapeutic CMC – development
  • IND/BLA development
  • Process development and validation service
  • Drug establishment registrations

Quality and Compliance

  • Quality manuals and quality systems implementation
  • CE Mark compliance development
  • Audit programs: (Compliance, CE Mark and CAPA verifications)
  • Corrective Action/Preventive Action (CAPA)
  • Dodd-Frank: Conflict Free Metals
  • Compliance training programs (ISO, GXP, GHTF)
  • Liaison to the FDA (Meeting preparation, submissions and FDA response)
  • Liaison to International Notified Bodies

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