Intertek is the industry leader with over 43,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Solutions and Consultancy to the Pharmaceutical and Medical Device Industries
Expert Services provides a wide range of regulatory, testing, environmental and safety consulting services to the pharmaceutical and medical device industries worldwide.
We have a global network of experts that helps customers in highly regulated industries to achieve compliance, efficiency and sustainable business success.
Our regulatory services include expert advice on all aspects of product development, whether the product is a human pharmaceutical, biologic, medical device, natural health product, combination product or cosmetic. We provide services in the following areas:
Integrating comprehensive regulatory and scientific experience into the design of early drug development strategies
Assisting with testing programs (protocol development, placement and monitoring of studies, review of final reports)
Conducting third-party Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) audits
Pre-empting regulatory concerns and questions through preview of data and submissions
Preparing or previewing submissions, from pre-meeting packages and post-marketing changes to full dossiers
Global chemical notification of intermediates
Chemical inventories, listing and product registers
Control regimes (CWC, drug precursors, dual uses, import / export)
Environmental management systems (ISO, OSHAS, EMAS)
Auditing, reporting, legal compliance and hazards management auditing
Environmental due diligence
Impact assessments (e.g. action tracking / management of change software)
Our speciality is non-routine problem solving through a combination of highly experienced and motivated staff and extensive state-of the art instrumentation. Our cGMP and GLP accredited laboratories offer a broad range of testing and consultancy services.
Structure elucidation and characterisation of complex formulations
Identification and quantification of transformation or degradation products