Element’s regulatory and industry experts have a proven track record of successfully developing and validating fit-for-purpose, accurate, and reliable analytical methods based on established CDER/ICH and FDA guidelines and procedures for highly complex formulations and sample matrices.
Analytical method development, validation, and transfer are integral to any small or large molecule drug development program. Analytical methods can be developed to establish the identity, potency, physical characteristics, and purity of an active pharmaceutical ingredient (API) in compounded dosage forms, as well as identify and quantify impurities, excipients, intermediates, raw materials, preservatives, antioxidants, and more. To establish consistent scientific soundness of a method and ultimately safeguard patient safety, any analytical methods used to analyze drug products or drug substances for regulatory submissions must be validated, as required by regulatory agencies at various stages of the drug development and approval process. Rigorous method validation establishes the accuracy, precision, linearity, specificity, selectivity, limits of detection and quantitation, and robustness of an analytical method.
Our flexible and customized solutions, including phase-appropriate analytical method development and validation, are tailored to meet your specific needs throughout the drug development lifecycle, from early-stage protocols to late-stage quality control method optimization.
GMP analytical method verification, transfer and optimization
Monograph and compendial methods found in pharmacopeias have been validated, and unless stated otherwise, full validation is not required prior to use. However, verification is needed to confirm that the method is suitable for its intended purpose, including the specific drug product, substance matrix, and use conditions. Our consultative analytical method development services team has extensive experience and expertise in method verification techniques, including those detailed in USP <1226> Verification of Compendial Procedures.
When you partner with Element, analytical method transfers are smooth and efficient with standard operating procedures and protocols, whether products require comparative testing or inter-laboratory method validation. Our consultative analytical experts are available to train teams at receiving sites, ensuring regulatory requirements are met, including those detailed in USP <1224> Transfer of Analytical Procedures. Similarly, Element can easily carry out the transfer of developed methods to production sites, and our highly skilled method development scientists can seamlessly transfer existing analytical methods into our laboratories for direct testing use and/or optimization.
Experience with a wide variety of sample matrices
- Powders and granules
- Oral and topical liquids
- Creams, ointments, and gels
- Combination products
The Element advantage
We offer a comprehensive suite of flexible and customized solutions, including phase-appropriate method development and validation, to meet your needs at every stage of the drug development life cycle. With a strong foundation of proven success in developing, validating, optimizing, and transferring complex and challenging analytical methods and purposefully equipped laboratories with a wide range of advanced analytical instrumentation, our analytical method development services team has the expertise and knowledge to take on highly complex compounds and drug products.
To learn more about how Element can deliver high-quality, validated methods or to speak with one of our experts, contact us today.
- API and drug product methods
- Raw material and in-process testing
- Potency and purity methods
- Impurity identification, isolation, and structure elucidation
- Residuals testing of biological processing aids (surfactants, gravitational aids for ultra-centrifugation, i.e. iodixanol, poloxamer)
- Stability-indicating methods
- ICH stability programs
- Forced degradation studies
- Container-closure testing
- Extractables and leachables studies
- Release testing
- Custom assay development
- Characterization of drug substances
- Drug excipient compatibility studies
- Pharmacokinetics (PK), parmacodynamics (PD), bioequivalence (BE), and bioavailability
- Reference standard characterization and management
- Vendor qualification
- Design of limit tests (e.g. surfactants) to support clearance and cleaning validation studies
- Gap analysis and remedial validation
- Specification and other regulatory filing documentation preparation
- Q1/Q2/Q3 deformulation for generic drug development
- Physical characterization for analytical method development and validation
- Analytical method life cycle management
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
Forced Degradation Studies
Element’s forced degradation, stress testing services per ICH Q1A guidelines assess the stability of drug substances or drug products with effects on purity, potency, and patient safety.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.