Our pharmaceutical services are dedicated to both small molecule and biologic drugs, helping you to overcome the challenges of drug development and manufacturing.
With Intertek as your partner, you can trust us to provide a single source solution with expertise that fits your unique needs for both pharmaceuticals and biopharmaceuticals. Our pharmaceutical scientists and regulatory experts work with you at every stage of development, providing a comprehensive and flexible service to help you gain a marketplace advantage. Over the last 20 years our network of Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) laboratories has provided high quality technical services for some of the world’s largest and most innovative pharmaceutical companies.
GMP and CMC Laboratory Services
We also 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, 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 biologic therapeutics.
During preclinical and clinical development, our and bioanalysis experts design and manage strategic work programs. Our expertise and industry insight aims 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.
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 comply with global regulations.
Our pharmaceutical auditing and management services give you a transparent view of your supply chain. 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.
Consumer Healthcare Clinical Trial Services
Our clinical trial services for low risk investigational medicinal products and medical devices include specialist capabilities in dental, dermatology, podiatry and wound management. Led by experienced investigators, our multi-disciplined clinical teams provide robust clinical trial services compliant with ICH GCP and ISO 14155 to support your consumer healthcare, over-the-counter medicine, and medical device product development.
Pharmaceutical Manufacturing Support
Expert cleanroom services, equipment calibration and on-site inspections can help your manufacturing to increase efficiency and meet safety and compliance goals, while our cost-effective eLearning modules will equip your staff with essential information on the latest in quality and compliance. Manufacturing support expertise includes problem solving analysis, pharmaceutical supply chain surveillance for counterfeit medicines, falsified medicine and counterfeit medicine analysis and materials science knowledge.
Intertek’s innovative pharmaceutical services can underpin the research, development and manufacture of your drugs. You can rely on our years of experience and global network of laboratories and specialists for a level of support that’s second to none.
Auditing and Systems Certification
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