Peritus Regulatory

Peritus Regulatory is an expert "one-stop-development-support" organisation for the development of therapeutics (small molecules, biologics, cell & gene therapy) and medical devices (including combination drug/device approaches). https://www.peritus-regulatory.com/ Our highly experienced team can help you with almost any aspect of development for therapeutics and medical devices – with a substantial network of associates, Peritus Regulatory can guide you through solving development plans & issues. We work across the life science ecosystem from early-stage biotech to in-market biopharma, and we support investment organisations with their portfolio companies and potential investments / due diligence. Peritus Regulatory provides: Regulatory Expertise in Development & Submission and On-going in-market support. Regulatory compliance throughout the product lifecycle is paramount. Therefore, well designed regulatory strategies are pivotal for product development together with timing for regulatory applications & discussions with approval bodies. https://peritus-regulatory.com/regulatory-services/ Safety Toxicology, Pharmacology, CMC and Pathology - Peritus has nonclinical / preclinical toxicology and safety specialists - adding significant value to projects with pharmaceutical & biotechnology companies, CROs, SMEs, spin-outs and academia. https://peritus-regulatory.com/safety-toxicology-cmc-services/ Medical Device – Peritus Regulatory has substantive experience in medical device regulation in EU/USA/UK/APAC. https://peritus-regulatory.com/medical-device-regulatory-compliance-services/ Clinical Research Expertise up to phase III therapeutic development. Our team are experienced ex-industry and CRO individuals. https://peritus-regulatory.com/clinical-research-services/