Preclinical Development

Technical guidance and management of preclinical development programmes

R&D and Programme Management

Complete solutions to R&D and clinical programme planning and management

Formulation and CMC Product Development

Extensive technical and CMO management support for new product development, re-formulation and product re-purposing

Manufacturing Process Design and Control

Development of scale-up strategy, technology transfer and commercial manufacturing planning

Technical Due Diligence and IP support

Technical data review, product and portfolio assessment, IP development, review and FTO technical analysis

Welcome to H2 Pharma Consulting

Founded in 2007, H2 Pharma is a privately owned international pharmaceutical consultancy company that provides comprehensive product development services to the Biotech, Pharmaceutical and Medical Device Industries.

The scope of our services span the spectrum of drug product development activities from early pre-clinical evaluation through to full development, commercial technology transfer and product registration. We support the development of human health products (Ethical Rx, Generics and OTC) as well as veterinary health products and medical devices. We specialise in drug re-purposing development, having enabled the commercialisation of a number of high-profile products from initial conception through to successful registration over the past 5-years.

Our ethos is to work in an integrated manner with our Clients to plan, execute and manage R&D development programmes from the early stages of feasibility development through to product registration and commercialisation. We also provide extensive technical, intellectual property (IP) and project management support for all aspects of non-clinical CMC development, including: formulation and process design, manufacturing, process scale-up and regulatory CMC.

Our feedback

We engaged H2 Pharma initially to review and advise on a proposed manufacturing scale-up process. This remit quickly broadened as the breadth of their expertise and usefulness across the entire R&D pathway became apparent. Their input undoubtedly saved us time and money; firstly by re-prioritising and streamlining our program plans, and secondly by facilitating alliances in key areas. I have no hesitation in recommending their services.

Dr Robin Quirk
CEO, Locate Therapeutics, UK

Working in collaboration with our product and applications development scientists, H2 Pharma significantly accelerated Colorcon’s understanding of the science, formulation and process development of osmotic-driven controlled release tablets. This in turn allowed our field teams to guide our customers through, faster, and first-time-right, development of these complex forms. Thank you.

Dr David Bain
General Manager, Colorcon Inc., UK and US ()