GxP Strategy Consulting

As a best practice, inspection readiness is a continuous, ongoing program dedicated to consistently maintaining high-quality processes and deliverables. From the standpoint of a regulatory authority, organizations must be inspection-ready at any time. During its course, the inspection aims to verify that processes and systems are compliant with regulatory obligations supporting the safety and wellbeing of trial participants, and that the data is reliable. A risk-based, forward-thinking approach assures that quality processes are always embedded throughout clinical trial programs for full compliance and inspection preparedness.

Small and midsize companies as well as larger enterprises with a sizable development pipeline rely on Allucent to support them in developing and implementing their global GxP strategies. Our team is highly proficient in providing strategic guidance and advising on complex GxP issues as they arise. We also offer support in investigating and resolving compliance issues in all phases of research and development.

With deep expertise in clinical trials, our A-team has decades of experience in legislation and compliance as well as pharmacovigilance; several have served as inspectors with regulatory agencies. Quality processes are only as effective as the commitment of the people who carry them out. Hence, we take a personal, hands-on approach, working closely with your team to develop a quality culture.

GxP comprises Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Pharmacovigilance. We are available as consultants on your study or to answer any question related to pharmacovigilance. Our scope of GxP services includes:

• GxP compliance assessment
• TMF audits
• Clinical investigator site audits and vendor/service provider audits [routine or “for cause”]
• Database audits
• Regulatory agency inspection readiness
• Support for regulatory agency inspections [“Back room”]
• Mock inspections
• GxP or GCP training
• FDA Form 483 and warning letter response assistance
• Vendor qualification
• Create SOPs and support on:
  • Authoring
  • Review
  • Gap analysis
• QMS development
• GLP Audits
• Data quality audits
• GMP Audits
• Quality Management system (QMS) development
• Establishment of quality agreements and manuals
• QA review of master/executed batch records, specifications, test methods, validation and stability, protocols and reports
• PAI readiness assessment and training