Quality & Compliance

Beacon Hill Pharma has the Quality Assurance resources to ensure compliance across all phases of the drug development lifecycle. From establishing Quality Systems and Quality Management Plans to site and vendor audits, Beacon Hill Pharma has the expertise to handle all of your Quality needs.

Service offerings:

  • Mock Inspections/Site Readiness
  • GxP Audits: Routine, for cause, Pre Approval Inspection
  • QA Subject Matter Experts
  • Developing, Implementing, and Overseeing Quality Systems
  • Quality Management Plan Development and Implementation
  • Document control: review, writing and template development
  • Corrective and Preventative Action Plans: Development, Implementation, and Close Out
  • Regulatory response preparation and review (483 Letters)
  • SOP development and review
  • Validation

Internal and external GxP auditing of sites to include: manufacturing facilities, CROs, investigators, monitors, suppliers, vendors, contract laboratories, QC laboratories, central, specialty, and analytical laboratories, licensing partners and agreements, internal departmental audits, etc.

Explore Beacon Hill Pharma's Offerings & Delivery Models and Case Studies.

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