Members of Acumentia that specialise in product and ingredient analysis have held senior positions in the pharmaceutical and environment science industries. Acumentia’s technical consultants understand that thorough analytical testing underpinned by convincing, well-presented data is integral to the successful manufacturing and marketing of all products. We offer a range of testing services that don’t only ensure your products are compliant with the latest regulations and legislation, but also provide precise data that actively feeds into their on-going redevelopment.
Many of the analytical problems that arise are highly complex and associated with issues such as product development (specification and quality), patent challenges, ICH stability trials, regulatory approval, complaints and product functionality. Also, exact compositional analysis is imperative to make sure your products conform to the rapidly changing legislation currently governing product manufacture.
Each one of our highly trained Acumentia consultants is revered within their own industry for their commitment to quality and product development. A number of the consultants are world experts in highly complex areas such as polysaccharide chemistry, rheology, spectroscopy and chromatography. They are familiar with the requirements of a range of quality management systems and will work alongside clients to ensure that contracts are completed to budget and on time. The specification and selection of analytical equipment, development of new methods, preparing validation protocols and system suitability testing, all fall within the remit of our consultants.
Acumentia consultants support our clients throughout the drug development process. We work with APIs, small molecules and biologicals, formulations and medical devices. Acumentia can develop, validate and troubleshoot your release methods, characterise NCEs and manage your stability studies. Preformulation development, including excipient compatibility studies, solid state studies (polymorphism, salt formation etc.) are all areas we encompass. The development of new products often requires a high degree of analytical input from the design of suitable ingredient extraction and purification processes to determining final product chemical and microbiological specifications. Methods are developed and validated according to ICH guidelines including the transfer of pharmacopoeial and non-pharmacopoeial methods. It is often necessary to deal with the US FDA for regulatory approval and members have been involved with the production of monographs for the US Pharmacopea.
Acumentia consultants routinely work to the usual industry standards (USP, EP etc.) and are not only experts in the design and implementation of dynamic testing techniques, they are fully conversant with the guidelines of GMP and GLP, but are also adept at delivering logical, profitable conclusions based on thorough interpretation of the results attained.