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

Bioneer has worked with H2 Pharma and Dr Hiep Huatan for a period of approximately 3 years. In that period Dr. Huatan was Bioneer’s International Sales and BD manager in a specific area related to biorelevant dissolution testing. He managed to attract a number of good customers and brought key assignments on board, not at least because he is very professional and skilled in the art of understanding customer needs. We would unreservedly recommend the services of H2 Pharma.

Dr Lars H. Pedersen
Chief Business Officer, Denmark ()

We have collaborated with H2 Pharma Consulting on several development programmes covering a diverse range of dose formats for customers operating in many different sectors. On each project that we have partnered with H2 Pharma we have witnessed that they demonstrate a high level of expertise in clinical and product development, routinely providing strategic direction and customising their approach to the specific requirements and objectives of the client. Their flexibility in approach, a proactive attitude to risk management together with their deep understanding of the FDA and EMA regulatory requirements means that they routinely deliver high quality results and work packages in an efficient and timely manner. H2 Pharma are skilled at managing project teams, setting common goals and take ownership in motivating team members to achieving milestones in line with the required timelines. They have proved to be a very capable and valuable partner for Co-Formulate.

Nazim Kanji and Huw Jones
Directors, Co-Formulate, UK