ERA Consulting (UK)
ERA is able to contribute at any stage of product development, from discovery, through process development, non-clinical and clinical aspects, to regulatory approval and beyond. One of our recognised specialities is the design of a regulatory strategy, to cover part or all of the development process. Thus, our services include the following: Regulatory due diligence exercises for in- or out-licensing, interactions with regulatory agencies, such as pre-IND, pre-BLA and scientific advice procedures, clinical trial applications, marketing authorisation applications, including eCTD submissions, post-approval amendments or variations, advice on process development, including validation, input on characterisation and control, consulting on non-clinical and clinical strategy, facility inspections and support for establishment licensing.
Selcia, now part of Eurofins, is a global leader in 14C custom radiolabelling, stable isotope labelling and analytical services. With many years of experience our team of expert synthetic radiochemists can prepare radiolabelled molecules of almost any complexity for use in regulatory studies by the life sciences and chemical industries to understand: preclinical and clinical drug metabolism, human mass balance (GMP 14C Radiolabelled API), dermal penetration, tissue distribution and environmental fate. Selcia also offers GLP NMR and analytical problem solving services to support regulatory submissions, as well as the profiling and synthesis of metabolites and process impurities. www.selcia.com
- 14C Custom Radiolabelling for pre-clinical studies (ADME, Dermal Penetration, E-fate)
- GMP Radiolabelled API for Clinical Trials , 14C-API for hAME and mass balance
- Stable Labelling (13C, 2H, 15N) Internal Standards, Metabolites and Impurities
- GLP Analysis Certification and Problem Solving including GLP NMR
Radiolabelling to support Life Sciences: • Metabolism • Distribution • Mass Balance • Micro-dosing • Environmental fate • Dermal Penetration