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 »
With the advent of biologics, mono clonal antibodies, gene and personal directed therapies, have meant the days of the ‘tick box’ approach to the regulatory phases of nonclinical pharmaceutical development is passing by quickly, and whist the regulatory guidance changes as fast as possible, it lags behind the science. There is a concern that
Nonclinical Drug Development- The Dawn of a New Paradigm Read More »
Drug development is a balancing act. On one side, extensive and often expensive testing is required, but on the other is a need for patients who may have few or no treatment options to receive novel medications quickly. Access to safe and effective treatments for all patients is a key consideration for Regulatory Agencies when
Expedited Regulatory Pathways and Health Authority Advice Read More »
The Medical Device Regulation (MDR) 2017/745/EU is now in force and brings a number of changes which will impact on medical device developers and also those with products on the market. There are a number of significant changes in the regulation affecting products in development and in-market: Scope of medical device “definition” has increased With
Medical Device Regulatory Update Read More »