We Are Experts

Regulatory Services

  • IND – complete Module 3 build
  • IND – complete Module 3 review
  • IND – Periodic Module 3 updates
  • PIND – complete CMC build
  • PIND – CMC representation at PIND meeting
  • Regulatory strategy map
  • ISO 17025 accreditation implementation

Quality Assurance

  • Complete QMS build
  • QMS gap assessments
  • Oversight of batch records and operational protocols
  • Specification build and approval
  • Risk assessment
  • Gap assessment
  • Extractables and leachables programs
  • Complete quality representation for CMO and CRO
  • Quality audits for API, DP, laboratory, GLP, and clinical sites

Quality Control

  • Complete laboratory oversight
  • Review and approval of protocols, reports, TPs
  • Complete support for pre-GLP, GLP, and GMP testing
  • Complete support for phase-appropriate TP qualification/validation
  • Stability program strategy and oversight
  • ISO 17025 gap assessment

Operations

  • On-site oversight of manufacturing
  • Technical batch record oversight
  • Process feasibility oversight
  • Equipment validation strategy
  • R&D support for formulation development
  • R&D support for process development

Project and Program Management

  • PMP-certified project manager
  • Lead or support project management at CMO, CRO
  • Manage archive of documents and records
  • Program planning for clinical programs