Exponent offers the highest quality technical, safety assessment, pre-clinical, and clinical research, epidemiological, and health economics services to assist our clients with issues related to pharmaceutical and drug delivery products. We specialize in providing rapid, comprehensive, focused, market-sensitive solutions to complex issues through a skilled multidisciplinary team. The breadth of our expertise makes our assessments thorough, efficient, and cost-effective. With issues related to introduction of new advanced pharmaceutical drug products, new technologies such as advanced delivery systems, new entities of bio-molecules, and new indications, our clients face numerous challenges today in getting products to market. Exponent’s services include developing appropriate preclinical and clinical plans to evaluate safety and efficacy, and preparing the scientific basis for compelling regulatory submissions nationally and internationally. Also, with the industry trends of acquisitions and mergers, our clients face new technology assessment and licensing decisions.
We bring a multidisciplinary approach to address a wide range of pharmaceutical and drug delivery issues, applying expertise in pharmaceutics, medical devices, bioengineering, biomechanics, biostatistics, electrical engineering, clinical research, epidemiology, exposure assessment, health economics, human factors, biomaterials and materials sciences, mechanical engineering, medicine, regulatory affairs, and toxicology. Complementing our technical expertise, our team members are well versed in regulatory, intellectual property, and product liability issues.
Our capabilities and services in pharmaceutics and drug delivery include:
We assist clients with pharmaceutical drug product technology assessment, licensing decisions, and due diligence, including market evaluation, opportunity and strategy, technology assessment, competing technologies evaluation and benchmarking, regulatory hurdles assessment, development planning, intellectual property assessment, and patent reviews. We have extensive expertise in providing scientific and technical assistance for patent prosecution and handling technical evaluations for patent infringement disputes.
Combination Drug Product Development
We assist with combination drug product development, and chemistry, manufacturing, and control (CMC) issues, during pre-clinical, clinical, and post-marketing development phases, including toxicology, pharmacology, formulations development, and improvement; delivery systems design, development, and improvement; formulation and delivery system compatibility, formulations, and delivery systems manufacturing and process scale-up; and stability of drug/device combination products, product performance optimization and improvement, and product safety and reliability.
We also have expertise in the design, development, performance evaluation, and optimization—as well as safety and human factor evaluations and ergonomics—of drug delivery devices, including inhalation delivery systems such as propellant metered dose inhalers (pMDIs), dry powder inhalers (DPIs), and nebulizers; powder design and coating technologies; controlled-release polymers and hydrogels; oral, transdermal, and buccal deliveries; and medication delivery pumps.
Design and Testing
We assist clients who require a scientific approach to design and testing, by employing controlled design of experiments to evaluate pharmaceutical products. Our consultants have expertise in a wide variety of characterization methods and techniques, including:
- Aerosol testing
- Evaluations and measurements
- Particle size analysis and measurements
- Aerosol plume characterizations
- Powder characterization and design
- Dissolution techniques
- Analytical methods evaluations
- Developments, verifications, and validations
- Characterization and evaluation methods development and validation
- Physical, chemical, and biological characterizations of polymer-based biomaterials
- Materials characterization and selection
- Fluid-flow computation and analysis
- Finite-element and stress analyses
- Engineering and fracture mechanics and fatigue evaluations
- Vibration and acoustic testing
- Ergonomic assessment
- Software development
- Software failure modes and effects analysis (FMEA)
We have experience in risk management and performing design reviews using techniques such as fault-tree and FMEA.
We can assist our clients in manufacturing-process analysis and improvement; trouble-shooting and process FMEA; as well as process verification, validation, and statistical process control. We have extensive experience in handling root-cause analysis to identify issues that could be leading to manufacturing inconsistencies and to products failing to pass quality control metrics.
Regulatory Compliance and Quality Assurance
We have expertise in supporting regulatory strategy development for pharmaceutical drug product registrations in the U.S. and internationally by working alongside our clients’ regulatory teams. Exponent scientists have successful experience with the regulatory agency interactions necessary for product submissions, clinical and technical development plans, and post-marketing issues. We also assist our clients in quality systems implementation and improvement for compliance with Good Laboratory Practices, Good Manufacturing Practices, and ISO 9000, as well as manufacturing procedures analysis.