Environmental Risk Assessments (ERAs) Therapeutic Drug Development Recently we have had a number of enquiries and subsequent projects to utilise Peritus’ expertise for our Environmental Risk Assessment (ERA) services. Here, our Head of Toxicology Services, Dr Richard Reece-Jones briefly provides background information on ERAs. ERAs are not new – the EMA has required […]
USA Regulatory Affairs European Expansion Support Read More »
Therapeutic Drug Development: What’s this CMC and Why should I think about it early in development? An area of therapeutic development that needs early and on-going consideration is CMC (Chemistry, Manufacturing, and Controls). At the onset of product development, a manufacturing process needs to be designed and developed to achieve the desired product, accompanied by
Importance of Regulatory CMC Read More »
With staggering investment into the life science sector within the last 2 years – there has been a significant rise in demand for regulatory affairs and product development expertise. Coupled with the practical manifestations of the pandemic and evolving regulations – the demand for experienced permanent Regulatory Affairs resources far exceeds current supply – this has
Lack of Regulatory Affairs Expertise to Fulfil Demand – What’s the Solution? Read More »
Peritus Regulatory is part of an established regulatory and nonclinical safety toxicology consultancy. This is a great opportunity to work with highly respected specialists in their disciples to deliver on a variety of projects with life science start-ups and established biopharma companies looking for expert support. We are expanding our footprint across several geographies including
Experienced Regulatory Affairs Consultants – Join the Peritus Regulatory Team Read More »