Peritus S2PD Development, Regulatory & Market Access Partners
EXPERT REGULATORY - SAFETY - TOXICOLOGY - MEDTECH - CLINICAL - CMC - MARKET ACCESS SPECIALISTS
Areas of Expert Support
Safety Toxicology, Nonclinical, Pharmacology, CMC and Pathology
Peritus has nonclinical toxicology / safety and CMC specialists - adding significant value to projects with pharmaceutical & biotechnology companies, CROs, SMEs, spin-outs and academia.
Regulatory Expertise in Development, Submission & In-market
Well designed regulatory strategies are pivotal for product development, timing for regulatory applications, discussions with approval bodies and in-market support.
Medical Device Regulatory Experts Supporting SMEs and Biopharma
Peritus Medical Device Group has the vital knowledge & expertise to support any aspect of Medtech Regulations, QA/RA Compliance, and Software QA where we are a leading provider.
Clinical Research - Strategy, Design, Management & Reporting
Expert clinical research group which is able to support, design, manage and report on product development from phase I onwards. Excellent experience with the Notified Bodies, and regulatory authorities (FDA, MRHA, BSi etc).
Market Access / Health Economics Expertise for UK & Europe
Our expert Market Access / HEOR team helps life science and medtech companies plan and practically implement market access pathways in UK/EU.
Peritus encourages clients to take a considered and strategic outlook from an early stage.
Developing a product development programme in line with a coherent regulatory strategy can ‘smooth’ the commercialisation pathways. This holds true for small molecules, biologics, ATPMs, medical devices & digital therapeutics – helping with programme costs and investment decisions.
Where there may be many uncertainties – Peritus Regulatory can advise.
Adapting to the changing technical & regulatory demands for product development
The emergence of new types of medicines such as advanced therapy medicinal products (ATMPs) and novel vaccines presents with different issues in terms of early stage nonclinical / preclinical product development as compared small molecules.
With our thorough understanding of the development space and the regulatory demands Peritus is well placed to offer pragmatic advice and solutions to meet the needs of our clients.
During the Covid-19 crisis, Peritus was involved in the provision of toxicology, safety, nonclinical, Chemistry Manufacturing & Controls (CMC)* and regulatory support to companies in vaccines development and with delivery mechanisms including inhalation.
* Often under-estimated, the role of CMC is critical to all stages of therapeutics development.
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