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.
Eurofins Selcia Drug Discovery
Selcia Ltd is a leading provider of contract research services in drug discovery and 14C radiolabelling. In January 2018 Selcia became part of Eurofins Pharma Discovery Services affording Selcia the capacity to deliver extensive and seamless solutions and services that span the whole spectrum of drug discovery.
Selcia Drug Discovery focusses on integrated small molecule drug discovery, with a strong track record of IP generation and preclinical candidate delivery for customers – 25 patents and 11 preclinical candidates generated. USPs are the medicinal chemistry of macrocycles, and a peptidyl prolyl isomerase (PPIase) screening platform.
Selcia radiolabelling specialises in 14C GMP radiolabelling, producing 14C radiolabelled compounds for a global customer base encompassing both the life sciences and chemical industries. Applications of the radiolabelled products prepared by Selcia include: preclinical and clinical drug metabolism studies; mass balance, IV microdosing, dermal penetration, regulatory and environmental fate studies.
Selcia also offers GLP NMR and mass spectrometry services to support regulatory submissions, and specialised purification capabilities from analytical (µg) to multi-100g scale.
Areas of Expertise:
• Medicinal chemistry: Tool compounds; peptides; macrocycles; natural product chemistry
• Biology: Assay development; ADME screens; PPIase profiling
• Disease expertise: Anti-infectives; inflammation; CNS; pain; metabolic; oncology & ophthalmology
• Target classes: GPCRs; ion channels; enzymes; protein-protein interactions
• 14C Custom Radiosynthesis
• GMP 14C Radiolabelled API for Clinical Trials
• GLP/GMP Analytics – GLP NMR
• Metabolites and Impurities (Profiling and Synthesis), standards and stable labelled compounds