Contract pharmaceutical and biopharmaceutical GLP/GCP/GMP laboratory services, supply chain audits and regulatory guidance supporting drug development and production.
Intertek pharmaceutical contract laboratory services, regulatory guidance and supply chain assurance brings quality and safety to life to support your unique pharmaceutical or biopharmaceutical outsourcing requirements.
Our pharmaceutical scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible services that enable you to achieve a marketplace advantage. Over the last 20 years, our network of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (cGMP) laboratories and regulatory experts have provided high quality technical services ensuring Total Quality Assurance for some of the world’s largest and most innovative pharmaceutical companies.
With strengths in protein analysis in accordance with the ICH Q6B Guidance including protein structure analysis, physiochemical property determination, potency assays and product-related and process-related impurity testing, we can help you to achieve a "well characterized" protein drug substance or drug product. Supporting your product development, we apply our analytical expertise to identity confirmation, comparability, stability testing and batch release testing. Supporting our clients developing highly complex products, we provide characterisation and testing expertise for oligonucleotides, cell and gene therapies, viral species and vaccines. To ensure a safe and efficacious biologic product we are adept at developing and validating assays for bioanalytical pharmacokinetic (PK), toxicokinetic (TK), immunogenicity, and biomarker studies from early discovery through to late-stage clinical studies.
GMP and CMC Laboratory Services
We provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs seeing you through preformulation, formulation and product release. Our capabilities include centres of excellence for method development and validation, analysis, stability studies, extractables and leachables, solid state characterisation, elemental impurity analysis, cGMP quality control testing and cGMP batch release testing. Our teams have specialist expertise for complex medicines and drug delivery systems such as inhalation drug product development for pulmonary and nasal products or inhaled biologic therapeutics.
During preclinical and clinical development, our bioanalysis experts design and manage strategic work programs. Our expertise and industry insight aim to supply the answers you need as quickly and efficiently as possible. As a world leading provider of immunochemistry services and biomarker expertise for bioanalytical studies, we provide excellence in service delivery and support for your preclinical and clinical development of protein based therapeutics and other biologic medicines.
Our pharmaceutical auditing and management services give you a transparent view of your supply chain enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Through our shared audit programs, delivered by our global network of specialist auditors, you can benefit from rapid implementation, easier access to audit sites and potential cost savings.
Regulatory and Toxicology Consulting
From discovery to commercialisation, our pharmaceutical regulatory consultants provide a fast-track and cost-effective approach to allow you to gain market access for products and assurance that they comply with global regulations.
Pharmaceutical Manufacturing Support
Expert cleanroom services, equipment calibration and on-site inspections can help your manufacturing to meet efficiency, safety and compliance goals, while our eLearning modules equip your staff with the latest quality and compliance knowledge. In addition to establishing health-based exposure limits for active pharmaceutical ingredients, Intertek’s specialists are well-positioned to perform assessments and prepare reports that are compliant with the EMA guidelines. Problem solving analysis, supply chain surveillance for counterfeit medicines, counterfeit medicine analysis, expert witness and intellectual property support underpinned by unrivalled materials science experience, supports both manufacturing and post-production.
Bringing quality and safety to life, Intertek’s innovative pharmaceutical services are delivered consistently with precision, pace and passion, enabling you, our customer, to power ahead safely. By meeting your pharmaceutical outsourcing requirements precisely, our global network of laboratories and specialists offer a level of assurance, testing, inspection and certification support that’s second to none.
Auditing and Systems Certification
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