About Us
YOUR EXPERT REGULATORY & SAFETY SUPPORT TEAM
The Peritus Team has the breadth and depth of experience and expertise to support product development and regulatory affairs for therapeutic and medical devices.
For early stage development, Peritus provides a ‘one-stop-development’ team – ideal for start-ups, spin-outs, SMEs and early stage investors.
We support bio-pharmaceutical companies with development projects and on-going regulatory support requirements.
"...knowledge, expertise and experience which has been invaluable..."
"...thinking about the preclinical and regulatory requirements early has been critical to expediting development and securing investment..."
"...Peritus are pre-clinical safety experts with extensive biotech experience applicable to both established product types and new therapeutic approaches..."
Peritus are “highly knowledgeable about global regulatory strategy, requirements, and expectations, especially when it comes to the specific requirements of individual countries in the EU"
"…immensely helpful to our group while we submitted regulatory submissions to many countries worldwide for … phase 3 clinical trial. Because this program was moving forward under fast-track designation, we faced many unique challenges that Peritus’ deep regulatory knowledge helped us navigate"
Their "deep knowledge also helped us navigate the process of creating regulatory strategy and drafting and submitting IMPDs submissions”
“…deep knowledge of EU regulatory affairs proved invaluable as xxxxx was embarking on a global phase 3 trial"
"actively participated not only in helping to understand the nuances of dealing with multiple EU countries, but in document creation and review (eg, IMPDs, IBs)"
Their "capacity to think strategically yet also act at an operational level was appreciated by all.."
“…excellent capabilities to manage medical devices and IVD global regulations!”
“…. is an exceptionally knowledgeable regulatory strategist and medical device guru and is always willing to help, support and guide you (thank you!)”
The core Peritus delivery team is outlined below with the majority of projects managed in-house. On-site support available.
We have an extensive network of associates and academic contacts if required.
Most of our work is in the UK/EU and USA.
Kish (MBA, DPS, BSc) – Cofounder & Managing Director – is a human biologist by training and has been in Global Executive Commercial & Business Development positions in the biopharmaceutical industry (GSK & Merck Serono). He has worked for almost 20 years in early stage life science technology commercialisation having taken several products to clinic and market. Kish also works with the investment community to provide due diligence and technology analyst services. He is the founder of Peritus Regulatory – recognising the need for expert development support for therapeutics and medical technologies across the product lifecycle including market access support. Kish manages all the commercial and management activities for Peritus Regulatory and leads on Market Access programmes and Business Development worldwide.
Richard (D.Prof, C Biol, ERT, FRSB) has >35 years experience in the non-clinical space having worked in industry (AZ, Renovo) and with CROs (Covance) and is Co-founder and Technical Director. He has developed and driven through many pre-clinical packages for pharmaceutical, biological and cell therapy companies. Experience of all regulatory pre-clinical species, regulatory toxicology studies, routes of administration & duration including safety pharmacology, genotoxicity, reproduction, acute & chronic toxicity, carcinogenicity, implantation, metabolism and ADME studies. Richard is an EU registered toxicologist, Chartered Biologist and leads the nonclinical operational activities at Peritus.
Neil (PhD) is Regulatory and CMC technical expert with ~20 years of experience in developing and implementing global strategies for pre-clinical, clinical and commercial biologic products. He was previously Head of Global Regulatory CMC and Compliance at Novartis Vaccines and Diagnostics. Neil has extensive experience with early phase CMC development of monoclonal antibody biosimilars, vaccines and novel therapeutics, together with authoring briefing books, conducting face to face scientific advice meetings with US and EU Agencies, providing regulatory strategy, CMC technical support and authoring of IND / IMPDs / MAAs and internal procedures. Neil is our technical CMC Regulatory lead.
Angela (MSc CSci CChem FRSC FTOPRA) is a Regulatory Affairs and Quality Management professional with over 30 years of regulatory affairs and quality experience gained in both CROs and pharmaceutical/medical device companies. She is experienced in medicinal product and medical device development, quality management system setup, maintenance and training, auditing for GxP, clinical trials, registration, post marketing variations, line extensions and life cycle management being well versed in ICH, FDA and CHMP guidelines. Angela has a scientific background with qualifications in chemistry, mathematics, pharmacology and toxicology, is a fellow of TOPRA having been President in 2018. Angela is our regulatory lead.
Nick (PhD) has > 25 years experience in preclinical discovery and early development activities across a range of disease areas. He has previously held senior positions in Pharma (Pfizer) and Biotech (Renovo, TCD Pharma, Atlas Molecular Pharma) sectors, leading multidisciplinary teams as well as working with CROs and academic/industrial collaborators. Nick’s expertise and leadership has contributed to the building of therapeutic pipelines and the translation of a number of innovative approaches into clinical development across small molecules, biologicals and cell therapies. He has authored 38 scientific publications (e.g., Lancet, Drug Discovery Today, Expert Opinion on Investigational Drugs) and is a co-inventor on 37 patents/applications. Nick has also contributed to the generation of dossiers for IND and CTA and has been the scientific representative on multiple therapeutic programmes in meetings with FDA, EMEA and MHRA. Nick is our pre-clinical discovery and translational research scientific lead.
Kip (MBA, BA) has over 27 years of experience in the pharmaceutical and biotech industry with specific functional expertise in quality assurance and regulatory affairs, GMP and IT compliance, technical operations, and product supply. His strategic leadership expertise includes business transformation, new business development, organizational change leadership and program/project management. He has led business process management groups at the global level during M&A, first at Wyeth Manufacturing (pre Pfizer merger) and later at Merck Research & Development (post Schering-Plough merger). Kip has held leadership roles in multiple early & growth stage pharmaceutical and biotech start-ups. Kip is our Business Development Lead in the USA.
