Our Services

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Compass Life Science Solutions has a well-established staff with extensive experience in the life science industry spanning multiple areas of expertise. Our expertise includes:                                                                                                                                                                                                                                                                                                             

  • Advising executives on critical compliance needs, risk mitigation strategies, remediation plans, Regulatory Agency expectations, EU Medical Device Regulation (MDR) compliance, and project management services
  • Assisting clients in composing responses to Inspections and Regulatory Actions, such as Warning Letters
  • Preparing organizations for regulatory audits related to US-FDA, EU, Canada, and HIPAA
  • Providing clients with GxP Quality Assurance support to ensure compliance with current regulatory expectations
  • Helping clients to achieve compliance with data integrity in relation to US-FDA, MHRA, and EU guidance and regulations
  • Providing clients with submission support
  • Providing training and performing audits related to 21 CFR Part 11, 58, 210, 211, 312, and 820, Annex 11 and 15; ISO 9001,  10993,  12207, 13485, 14971, 15288, 19011, 27000, and 62304; HIPAA; CAPA; GAMP; MDD; MDR
  • Implementing client quality systems (i.e. Quality Manual, risk management, vendor management, record retention, CAPA, design control, production and process controls, acceptance activities, nonconforming product, document management, product identification and traceability, purchasing controls, etc.)
  • Assisting clients with GxP computer system validation including software development and testing
  • Assisting clients with General Data Protection Regulation (GDPR) Compliance
  • Assisting clients with IT Governance Processes (i.e. Bring Your Own Device (BYOD), Acceptable Use Policy, Procurement, Logical and Physical Security, Service Management (ITIL Based), Account Management, Business Continuity Planning, Disaster Recovery, etc.)
  • Technical writing including SOPs, WIs, validation documents, etc.
  • Performing quality control reviews of clinical documentation for regulatory submissions including protocols/amendments, clinical study reports, Investigator's Brochures, CTD modules 2 & 5