CMC Analytical Services

Chemistry, manufacturing and controls (CMC) development strategies and Good Manufacturing Practice (GMP) laboratory services play a key role in helping you to reach your next milestone.

We are experts in developing, optimizing, validating, utilizing and transferring:

  1. Method development and validation 
  2. Impurity profiling
  3. Combined assay and Impurity
  4. Dissolution 
  5. Stability studies 
  6. Residual Solvent 
  7. Methods for genotoxic impurities.

We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP analytical services. Our expertise ensures sufficient information for your Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings. This is achieved through analysis services, pre-formulation and solid state characterization, method development and validation, stability studies, pharmaceutical impurity analysis, extractables and leachables and GMP batch release testing. Our scientists are adept at applying advanced technology in GMP compliant analytical development programs.  

Our formulation development scientists are experienced across a range of dosage forms including orally inhaled and nasal drug products (OINDP), oral, solid, liquid and transdermal or topical.  Strategic integration of formulation development with analytics ensures a detailed understanding of the pharmaceutical materials, their compatibility, physical properties and stability.  Our development teams offer but are not limited to cost-effective GMP Manufacturing Services for clinical trials aligned with IND or Common Technical Document CTD support which includes raw material characterization.

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