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:

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:

Strategic and Development Solutions

  • Global Regulatory Strategy
  • MDR and IVDR training and conversion planning for global device firms
  • 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

  • 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 –           — 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

 

For COVID-19 research information, click on this link.

You have Successfully Subscribed!