Quality

Complete Quality Management System (QMS) support including:

  • Gap Analysis
  • Quality Management Systems Build and Implementation
  • Internal Audits / Supplier Audits / Mock Audits
  • Design Controls / Design History File
  • Aseptic Processing and Cleanrooms
  • Product Development Reports
  • Reliability / Human Factors
  • Software Lifecycle Development
  • Risk Management
  • Complaint Handling
  • CAPA processes
  • Management Reviews
  • ISO 13485, ISO 9001, ISO 14971, IEC 62304, ICH Q7-10, 21 CFR 820, 21 CFR 210/211, 21 CFR 809

Chemistry, Manufacturing and Controls (CMC)

Full support of CMC processes for drugs, biologics and in vitro diagnostics including:

  • Aseptic processes / Cleanrooms
  • Test methods and QC testing
  • Preformulation and formulation development
  • Stability

Regulatory

Regulatory services for various regions and countries including:

  • 510k / PMA / NDA / BLA
  • IDE / IND / Updates
  • FDA Pre-NDA / Pre-Submission
  • eCDT
  • FDA 483 / Warning Letters Remediations
  • EU Technical Documentation / Clinical Evaluation Report (CER)
  • Production / Environments
  • Quality Management System Documentation

cGxP

Regulatory services for various regions and countries including:

  • Pre-Clinical / Clinical / Early Commercial
  • Validation IQ / OQ / PQ
  • Software Lifecycle Development and Validation
  • Process Flow / Optimization
  • QC GLP Test and Release
  • Peptides / Small Molecules / Biologics
  • Medical Devices / Combination Products / In Vitro Diagnostics (IVDs)
  • Cellular and Tissue products (HCT/P)