CMC, Manufacturing, Quality & Validation

Integrated development, manufacturing, and quality systems supporting pharmaceutical, biologic, and medical device programs.

Manufacturing & Quality Capabilities

End-to-end support from process development to global GMP supply.

Process & Analytical Development

  • Quality by Design (QbD) & Design of Experiments (DoE)
  • Scale-up and technology transfer
  • Formulation: OSD, sterile, topical, inhalation, parenteral
  • Method development & validation (ICH Q2)
  • Stability studies (ICH guidelines)
  • Extractables & Leachables (E&L)

cGMP Manufacturing

  • Clinical and commercial manufacturing
  • Drug substance & drug product (DS/DP)
  • Sterile fill finish
  • Lyophilization capabilities
  • HPAPI segregated production
  • Controlled substances handling
  • Packaging, labeling, serialization (DSCSA)

Medical Devices & Combo Products

  • Design transfer to manufacturing
  • Class I – III device assembly
  • Packaging & sterilization coordination
  • Device Master Record (DMR) / DMF
  • UDI compliance
  • Drug-device integration support

Quality Systems & Compliance

  • QMS: ICH Q10, ISO 13485
  • 21 CFR Part 11, 210, 211, 820 compliance
  • Internal & supplier audits
  • Inspection readiness
  • CAPA and change control
  • CSV & data integrity (ALCOA+)
  • Batch release & disposition

Validation & Engineering

  • Process validation (PPQ)
  • Cleaning validation
  • Aseptic process validation
  • URS / DQ / IQ / OQ / PQ
  • Facility & utility qualification
  • HVAC / WFI validation
  • Environmental monitoring
  • Sterilization validation
  • Thermal mapping

Supply Chain & Cold Chain

  • GMP warehousing
  • 2–8°C / 20°C / −80°C logistics
  • ERP & MES integration
  • Vendor qualification
  • Lifecycle supply chain management