GMP and CMC laboratory services to support pharmaceutical development; method development, validation, stability, formulation, batch release and extractables/leachables
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.
GMP and CMC laboratory services should 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 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, 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. 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 current regulatory guidance, our formulation and analytical scientists work with you to utilize exactly the right techniques to deliver the data you need to take the next step for both small molecule pharmaceuticals or biopharmaceuticals. With over 20 years of experience, we can help you to meet the appropriate quality and regulatory standards at each stage. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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