Pharmaceuticals: Chemistry, Manufacturing & Controls

Alerts

FDA Announces Plan for Advancing Regulatory Science of Materials in Medical Devices: A Look into the Future

How can Exponent help you evaluate the safety and performance of pharmaceutical products?

Whether you seek help with developing a new drug-eluting polymer stent technology, establishing validated quality control methods for drug impurities, investigating new hydrogel technologies, or testing the emulsion and dispersion properties of a newly developed medicine, Exponent's multidisciplinary approach provides breakthrough answers for your toughest challenges.

Our chemists, polymer scientists, and chemical engineers assist pharmaceutical manufacturers and medical product developers throughout all stages of the product lifecycle — from early-stage product development and testing services to manufacturing support, facility inspections, delivery, compliance, and product recalls.

Multidisciplinary expertise to assist you throughout the entire product lifecycle.

We help our clients source and test materials, manage chemistry, manufacturing, and controls (CMC) issues, validate material composition, evaluate chemical stability and degradation mechanisms, and investigate product failures such as contamination or non-uniformity.

Our wide range of expertise in chemistry, CMC, and macromolecular science provides technical expertise related to drug substances and drug products across a wide range of dosage forms. We leverage our experience across disciplines such as organic chemistry, inorganic chemistry, surface and polymer science, and manufacturing systems to support medical innovators with their pharmaceutical, combination device, and diagnostics products.

Capabilities

We focus on innovative, multidisciplinary solutions for materials, processes, and products starting at the molecular level, and apply our core competencies in chemistry, polymer science, and materials engineering to support all sizes and scopes of medical innovation.

Our experts routinely provide analytical test support or input on third-party test reports related to purity assessments, method verification, or custom stability investigations.
We assist clients with quality assurance (QA/QC) test method validation as part of technology transfer matters, root cause investigations, or to support regulatory filings.
The Analytical Chemistry Laboratory in Menlo Park is recognized as an ISO 17025 accredited laboratory (A2LA Certificate 2561.03). As applicable, the laboratory testing services are compliant with 21 CFR Part 58, U.S. FDA Good Laboratory Practices (GLP), and the laboratory holds a DEA registration for Schedules I — V.
Regulation of combination devices and formulated drug products continue to evolve as biomedical and pharmaceutical products increase in complexity and sophistication. Exponent provides the highest quality technical, regulatory, safety assessment, epidemiological, and health economics services to assist our clients with matters related to combination products. We specialize in providing rapid, focused, market-sensitive solutions to complex formulated products for the pharmaceutical industry.
Hydrogels are used in a variety of pharmaceutical and biomedical products, chosen for their ability to retain large amounts of water and maintain the shape of the intended product use. Exponent's polymer scientists are experienced in hydrogel research and provide critical insights for the advancement and use of hydrogel technologies for various applications. Our teams specialize in the design and evaluation of polymeric materials and small molecule additives and assist clients with materials selection, deformulation, and failure analysis of injectable hydrogel materials.
Medical plastics are used in a wide variety of applications, including sutures and mesh medical products used to close wounds, reinforce tissues, and as a surgical option for soft tissue repair. Our multidisciplinary team of scientific researchers and subject matter experts performs tests for new product development, examines failures of existing medical plastic components and assists clients with laboratory research in our state-of-the-art facilities. We have a breadth of expertise regarding the leaching effects of plastics and polymer products in biomedical wearable devices as well as the efficacy of medical plastics used for internal applications during surgery.
Our experts consult on numerous projects centered on the failure and degradation of polymeric materials used for medical devices and pharmaceutical products. We have experience with the formulation and characterization of polymeric, particulate, or emulsified products serving a wide range of industrial purposes, and we work extensively on stability issues in colloidal dispersions, emulsions, foams, and protein solutions. Additionally, we have worked with clients to develop emulsion-based technologies for microencapsulation and microreactor fabrication.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.