Areas of focus include:

Business

  Due Diligence

  Business Development

  Drug Licensing

Documentation

  ANDA, NDA and MAA

  IND and IMPD

  Marketing applications

Regulatory Affairs Services

  US and EMA

Strategy

  GMPs, Compliance, Consent Decrees

  Quality by Design

  Control Strategies

  Process Analytical Technology

  LIMS Design and Deployment

Training

Drug Development

  API Starting Materials

  API Route Development

  Process safety assessment

  Cost of goods evaluation

  Impurity Mapping

  PGI Assessment

  Analytical Method Design

  Method Validation and Transfer

  Physical Chemical Characterization

  Stability Study Design

  Specifications Development

  Formulation and Process Development

  Process Validation and Transfer

  Quality audit and PAI readiness

CMC Consulting