Our Services

OUR SERVICES

We provide a wide range of professional services to meet your needs. We are committed to providing a personalized  CMC end to end service for you.

Regulatory Affairs CMC

  • IND/IMPD/DMF/NDA/MAA expertise for drug substance and drug product eCTD authoring.
  • Design and implement regulatory strategies for pharmaceutical and combination products for early stage through commercialization.
  •  Regulatory agency meeting CMC oversight (Pre-IND, EOP2, Pre-NDA, Type C).
  • Change control management for all stages.
  • Technical CMC report authoring.
  • Advice on developmental, manufacturing, analytical, and supply chain challenges in relation to RA CMC.
  • Integrate with nonclinical and clinical development programs to ensure product availability.
  • sNDA strategy, authoring, and filing.

API & Drug Product Development

  • Identify and select project-appropriate laboratories/sites to conduct development.
  • Route evaluation, scale-up, and phase appropriate oversight at process and analytical sites
  • Regulatory starting material definition and designation.
  • Contract site management for development of synthesis and formulation.
  • Quality by Design (QbD) approach where appropriate.
  • Stability protocol design and implementation for API and DP. 
  • Couple technical development with regulatory requirements for efficiency.

Technical Transfer & Validation

  • Full oversight and ownership of process and analytical transfer to contract manufacturing sites.
  • Due diligence and guidance on CMO selection for API and DP.
  • Technical review of GMP documentation for manufacturing.
  • Project timeline oversight and defining key milestones with potential road blocks for technical site transfers.
  • Validation protocol drafting and oversight of validation studies at manufacturing sites.
  • Specializations in API manufacturing, tablet formulations, and various aseptic manufactured drug products.
  • Couple technical transfer activities with regulatory requirements.

Supply and Commercialization

  • Commercial launch readiness for new product introductions.
  • Integrate with technical transfer, validation, and regulatory functions to ensure supply chain readiness and reliability.
  • Generate and manage capital portfolio for commercial equipment and site including COGS/CIP.
  • Facilitate CLS and distribution team strategy and implementation.

End to End Project Management

  • CMC team management and oversight to drive cross-functional team members to overall program success. 
  • Microsoft project and other dedicated software expertise in end to end program CMC management.
  • Develop and implement strategic road maps for complex products and supply chains.
  • Advise key stake holders on program status and challenges while translating impacts, risks, and resolutions clearly.

Combination Products

  • Drug/Device expertise in development and commercialization of combination products. 
  • cGMP guidance in implementation of regulations for device and drug manufacturers.
  • Request for designation guidance.
  • Regulatory authoring and filing expertise for combination products including 505(b)2 routes.
  • Facility design and build for dedicated combination products.
  • Expertise in highly unique combo products that are new to the FDA.
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