Marble Pharma Consult (MPC) provides expert technical, quality and regulatory consulting services to pharmaceutical, biopharmaceutical or fine chemical companies involved in contract development and manufacturing activities of active pharmaceutical ingredients or formulated aseptic drug products.

Drug Substance and Drug Product Manufacturing

  • Complex synthetic and biological API’s: peptides, nucleotides, ADC’s, HAPI’s, fermented proteins, allergen extracts
  • Aseptic fill & finish: liquid in vials, lyophilized vials, pre-filled syringes
  • “Person in the plant” concept
  • Process scaling-up & validation
  • Process change: cost/benefit assessment and recommendation
  • Technology transfer (intra- and inter- companies)

Process development, manufacturing and supply chain management

  • Batch disposition (support to QA) and Quality audits
  • Stability programs consolidation and evaluation
  • Regulatory files redaction (CTD Mod 3), review and data integrity check, expert report redaction (QOS)
  • Compliance to regulatory commitments
  • Compliance to Technical Quality Agreement
  • Deviations and change controls assessment

Quality & regulatory services

  • Documentation packages supporting clinical development programs or registration files
  • Certificates of Suitability with the European Pharmacopoeia monographs
  • Interaction (written and meetings) with regulatory authorities (EMA, MHRA, FDA, EDQM)
  • cGMP and ICH Q7A compliance deployment and enforcement (audits); successful support to site inspections (FDA)

Business development activities

  • Market assessment and segmentation
  • Portfolio optimization
  • Commercial operations:
  • RFP/SOW preparation and support
  • Service agreements, development agreements, commercial supply agreements
  • Interim and Transition Management operations (Tech Ops, QA-CMC)

Sustainable CMC, Supply Chains and Operations

  • Environmental impact measurement of drug substance and drug product manufacturing
  • Predictive LCA approach for pharmaceuticals manufacturing
  • Data-driven carbon equivalents footprint reduction roadmaps
  • Sustainable operations and supply chain management
  • Quantifying of environmental impact and environmental performance