Chemistry, manufacturing and controls (CMC) and Good Manufacturing Practice (GMP) laboratory services to support your drug development requirements

Chemistry, manufacturing, and controls (CMC) and GMP pharmaceutical laboratory services play a key role in helping you to reach your next milestone. GMP and CMC contract laboratory services should help you to expose sources of risk early in development and provide sufficient information to assure the identity, quality, purity, strength, and stability of the drug product to meet regulatory requirements and specifications. When you prepare for an important submission, GMP analytical packages must demonstrate consistency and reliability of the manufacturing process which can involve specialist analytical expertise. To achieve the desired characteristics for the dosage form within project timelines, you will need formulation development knowledge, followed by clinical trial supply manufacturing that is both fully GMP compliant and monitors all areas of risk to ensure product quality.

Regulatory–driven CMC 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, preformulation 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.

Pharmaceutical knowledge to accelerate your development
With an experienced eye on the current regulatory guidance, our formulation and analytical scientists work with you to utilize exactly the right approaches and analytical methods to deliver the data you need to take the next step for both small molecule pharmaceuticals or biopharmaceuticals. With over 20 years of experience, our Total Quality Assurance expertise can help you to achieve the appropriate quality and regulatory standards at each stage of development.

 
GMP and CMC Services
GMP analysis for Active Pharmaceutical Ingredients (APIs) and drug products
Biopharmaceutical CMC solutions
Preformulation and physical characterisation
Method development & validation
Stability studies
GMP batch release testing
Extractables and leachables
Pharmaceutical Impurity Testing
Elemental Analysis and Trace Metals Testing for Pharmaceuticals
Inhalation and nasal drug product development
Formulation development
GMP raw material quality control testing
Pharmaceutical reference standard certification
Clinical Trial Supplies Services
GMP regulatory services
GMP auditing