Extractables and Leachables (E&L) studies and toxicology assessments improve the safety of next-generation nicotine products (NGPs) by ....
Pharmaceutical
Analytical Testing
Meeting Global Regulatory Requirements through Specialist Chemistry, Manufacturing, and Controls (CMC) Analytical Services
Whatever the requirements of your pharmaceutical project, we can help with a full range of GMP testing and analysis services. From early development characterization and formulation analysis to analytical method development, stability studies, extractables and leachable studies, and QC release testing.
Comprehensive Pharmaceutical Testing Services
When selecting a contract analytical and testing service provider, you need to choose a partner with a strong track record in successfully delivering high-quality, regulatory-compliant testing and the expertise to meet your commercial deadlines to deliver on your business goals. Our specialist services cover early-phase product development through to post market analytical support. With our testing services integrated with expert scientific and regulatory consultancy, additional insight and support are always available when needed.
Whether you are looking for a partner to work with on early-stage development, a regulatory submission, or to strengthen scientific understanding for post market compliance, our GMP laboratory facilities and in-house team of pharmaceutical subject matter experts will bring the insight required to your project to help it succeed.
Pharmaceutical Analytical Testing Services
Analytical Method Development and Validation
QC Release Testing
Stability Storage and Analysis
Extractables and Leachables
Product Assessment
Analytical Method Development and Validation
ICH Q2(R1) analytical method development, method validation, and technology transfer using cutting-edge technology and precision equipment.
QC Release Testing
GMP quality control release testing to qualify raw materials used in processes and establish that finished products meet quality specifications using client-supplied, in-house developed, or compendial methodology.Stability Storage and Analysis
On-site storage, study design, and analysis to support a development project, regulatory applications, and post market regulatory requirements with the analytical expertise on hand to advise and troubleshoot.Extractables and Leachables
In-depth testing and analysis to ensure a full understanding of potential leachable compounds in a container closure system, manufacturing process, or packaging that may impact a raw material, excipient, API, or finished product.GMP Testing Laboratory
Whatever your product category or area of focus, we can support you with a comprehensive testing strategy that helps build the scientific evidence and insight needed to gain regulatory approval and maintain compliance. Our scientific experts have extensive experience within the pharmaceutical industry and across a wide range of dosage forms.
- Commercialized pharmaceutical products
- Raw material, excipient, and API testing
- Early-stage and formulation drug analysis
- Medical devices with special expertise in inhalation devices
- Orally inhaled and nasal drug products (OINDP)
- Parenteral and ophthalmic products (PODPs)
- Biocidal products
- Solid dose formulations
- Veterinary medicines
Novel Pharmaceutical Product Development
If you are looking for a scientific testing and analysis partner to support the development of a novel product or new pharmaceutical innovation, our scientific and regulatory experts have years of combined experience delivering drug and device innovations across new API, excipients, and drug delivery systems.
Pharmaceutical Testing Services Resources
Learn more about how we can help bring your pharmaceutical product to market through our high-quality analytical testing services.
Pharma Inhalation Services
Developing and commercializing new inhaled drug products, requires huge energy and deep scientific understanding. This level of resource and subject matter expertise can be difficult to maintain inside your business, and that is where we can help.Pharmaceutical Services - Extractables and Leachables
The evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.Toxicology Advice and Consultancy Services
Our team of in-house toxicologists reviews and evaluates toxicological data on a wide range of chemicals to produce independent expert opinions on risk assessment. We then advise on the strategies to mitigate or reduce those risks to protect corporate reputation and public health.Learn more about our business and areas of interest
4 minute read
Extractables and leachables (E&L) testing is critical for identifying and quantifying potentially harmful leachable impurities from ....
6 minute read
Inhalation Therapy is a vital treatment for patients globally.