Projects & Clients

OUR CLIENTS

From small startups to established pharmaceutical companies, we support clients in need of technical and chemistry expertise in the pharmaceutical and biotech industries. These include:

  • Start-ups and emerging companies
  • Virtual drug development companies
  • Established pharmaceutical companies
  • Government drug development programs
  • Non-profit research institutes
  • Partners requiring CMC subcontractors for government contracts
  • Physician-scientists

OUR PROJECTS

CMC Pharma has vast experience with a wide variety of projects and
dosage forms. We’ve successfully led efforts to comply with the FDA’s
stringent requirements on formulation development, analytical development, and process development and control.

EARLY TO LATE STAGE PROGRAMS

  • Identifying optimal IND enabling project plans through NDA submission and approval
  • Supporting virtual product development
  • Identifying drug product dosage forms and drug supply strategy
  • Executing FDA and ICH compliant formulation, analytical and stability programs

DRUG PRODUCT DEVELOPMENT THROUGH POST APPROVAL

  • Formulation and process remediation
  • Identifying stabilizing strategies
  • Developing analytical methods
  • CQAs & CPPs and implementing proper control strategy
  • OOS and OOT investigations
  • Stability programs and failures
  • Validation of processes, methods and equipment

Drug Classes include

  • Small molecules
  • Biotech/large molecule products, including monoclonal antibodies
  • Potent compounds
  • Beta lactams, cytotoxics, hormones
  • Low solubility drugs
  • Unstable drugs

cGMP LAB SERVICES

  • Analytical development
  • Analytical Method Validation
  • Release Testing
  • ICH compliant Stability
  • Material compatibility

REGULATORY FILINGS

  • NDAs, supplements, and annual reports
  • INDs and amendments
  • FDA meeting requests and briefing documents
  • Field Alerts, warning letter & 483 responses
  • Orphan Drug Applications

TECHNICAL BUSINESS SUPPORT

  • Technical due diligence support of in-license and out-license of pharmaceutical products
  • Technical support of M&A activities
  • Business development support for programs with a significant technical component

STRATEGIC AND PORTFOLIO EVALUATION

  • Development of business plans and investor presentations
  • Solidifying product development strategies
  • Evaluation of portfolio options for development
  • Participate as product development team leaders & members
  • Identify non-dilutive grant funding

PHARMACEUTICAL SUPPLY CHAIN

  • cGMP supply chain strategy
  • cGMP manufacturing plans for development and commercial products
  • Confirming compliance with cGMPs
  • CMO and CRO evaluation and selection
  • Inspection responses to 483 and warning letters