GMP and CMC Pharmaceutical Laboratory Services

We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP pharmaceutical laboratory 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 characterisation, 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.

Integrated formulation, GMP analysis and clinical trial supply manufacturing
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 for small molecule and biologics. 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 cost-effective GMP manufacturing services for clinical trials aligned with IND or Common Technical Document CTD support which includes raw material characterization, sourcing, scale-up and pilot batch manufacturing to ensure product quality.