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)
- Global legislation development:
Environment, Health and Safety Services
We specialise in improving plant efficiency, environmental compliance and safety.
- Auditing / permitting support and concepts for technical solutions and BAT
- Optimised combinations of source control and end-of-pipe treatment
- Implementation and start up
- Environmental Testing
- Off gas sampling, waste water testing and analysis
- Occupational hygiene measurements
- Powder Safety Testing and Consulting
- Minimum Ignition Energy (MIE), dust explosivity (LEL, pMax, Kst, LOC)
- Minimum Auto-Ignition Temperature of dust clouds (MAIT), burning tests
- Process Safety and Thermal Stability Testing and Consulting
- Minimum kinetic and thermodynamic reaction data
- Thermal stability indices and maximum rate data
- Flammability limits of gases and vapours, reaction venting
- Process Hazard Assessment (training and/or project facilitation)
- Eco-efficiency and Sustainability, and Environmental Compliance
- Life cycle analysis, environmental labelling, material and energy flow analysis
- 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.
- R&D support
- Structure elucidation and characterisation of complex formulations
- Identification and quantification of transformation or degradation products
- Failure analysis
- Release testing of raw materials and final products
- Assays, residual solvents and microbiology
- Impurities and trace contaminants (nitrosamines, aromatic amines, dioxins)
- Method development and validation
- Development of new methods and optimisation of existing methods
- Validation according to ICH guidelines
- Transfer of methods and personnel training
- Qualification of reference materials
- Stability testing
- Storage according to ICH guidelines
- Analytical testing
- Identification of transformation or breakdown products
- On-line kinetic measurements
Services Specific to Medical Device Industry
Our practical experience in materials, packaging, regulatory and testing provides a unique offering to the medical device industry.
- Extractables and leachables studies
- Identification and quantification of extractables and leachables
- Determination of the role of additives in polymer formulations
- Recommendations for alternative stabilizers to achieve lower leachability
- Formulation of polymer test samples to evaluate potential leachables
- Numetrika™Antimicrobial efficacy and adhesion testing for medical devices and other products
- In vitro testing methodology for evaluating adhesive and antimicrobial performance
- Valuable R&D tool to determine appropriate concentrations of antimicrobials needed and their homogeneous distribution
- Supports quality control measurements for medical device industry
- Evaluation of surface treatment effects on microbial adhesion and /or proliferation
Why Choose Us?
- Expert Services provides regulatory, environmental and testing services to the pharmaceutical and medical device industries.
- We have extensive practical experience of navigating the world's regulatory agencies and procedures.
- We can solve your problems through our combined knowledge of plastic materials, additive packages and regulatory compliance requirements.
- We specialise in non-routine problem-solving with state-of-the-art instrumentation.
- We have experience of extractability / leachability and migration studies, as well as determining the role of additives in polymer formulations.
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