Services

CMC Development & Manufacturing

Process Development

  • Upstream (SPPS, LPPS, Hybrid Synthesis, Cleavage)

  • Downstream (Preparative HPLC/IEX/SEC, UF/TFF)

  • Product Isolation (Lyophilization, Crystallization/Precipitation, Spray Drying)

  • Early Formulation Development

  • Specification Development

Analytical Method Development & Validation

  • Raw Materials Controls

  • In-process Controls

  • Intermediate Analyses

  • Stability Testing

  • Release Testing


Manufacturing Strategy

  • Phase 1

  • Phase 2

  • PPQ

  • Commercial Manufacturing

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GMP & Regulatory Support

GMP Audits

GMP Documentation

CMC Regulatory Dossier

  • Review and assessment of Module 3 Documents

Pre-IND Meeting Support

  • Participate in agency meetings (e.g., pre-IND meeting support with the FDA)

  • Respond to Regulatory Agency CMC Questions

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Operations

CDMO Partner Selections & Management

Request for Proposal and Proposal Evaluation

Strategic Planning

Contract Negotiations (Proposal, MSA & Quality Agreement)

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