Formulation and Product Development

3D Pharma Consulting provides in-depth and holistic formulation and CMC development support for new product development, re-formulation and lifecycle management to enable new product opportunities.

Tailoring to your requirements, we can support the entire formulation development programme or parts, from the initial assessment through pre-formulation to product development, manufacturing, non-clinical and clinical testing. We provide up-to-date knowledge and expertise of established and emerging drug delivery technologies, formulation approaches, quality requirements and regulatory considerations. Throughout formulation and product development, we can assist with the compilation regulatory CMC documentation. Our formulation and product development services include:

  • Formulation strategy and design
  • Manufacturing process assessment, design, development and technology transfer
  • Sterilisation route assessment, testing and validation
  • Preparation of regulatory CMC packages
  • Selection and management of CROs and CDMOs
  • Development of analytical methods for product characterisation, stability programmes and drug-device compatibility testing
  • Requesting, executing and interpreting Scientific Advice from regulatory agencies

What Our Clients Think

Drawing on Paul’s track record of taking innovative processes from benchtop to GMP, we were delighted to work with him in preparing our technology for scale up. Paul understood our technology quickly, and provided us with a thorough analysis, relevant and practical advice and tangible output that was tailored to our needs as a small, but rapidly growing company

Dr Fran Crawford

CEO | SomaServe Ltd, Cambridge, UK

I would highly recommend Paul as a consultant; he has an in-depth knowledge of the pharmaceutical industry across a broad range of areas. Paul is proactive and works with clients to understand their objectives, he helped us to initiate a structured plan on how to enter the pharmaceutical sector and build a sustainable business model.

Ruth Mayes

Director Global Business Strategy | Computomics GmbH, Tübingen, Germany

Paul has brought a wealth of knowledge across pharmaceutical formulation development, analytical chemistry and manufacturing science. He has a positive, problem solving and professional manner that, combined with his industry knowledge, has provided Innoture with valuable support during internal and client facing drug development activities. His collaborative and friendly approach considers how Innoture is organised and our aims for the company, whilst also being keen to get his hands dirty w...

Ken Jones

CEO | Innoture Ltd

Working with Paul to develop long-acting injectable formulations has been an immensely helpful experience for us. Not only is he highly technically competent, but he is also incredibly easy to work with. His wealth of knowledge allows him to quickly understand any challenges we encounter and provide different methods to solve them in a timely manner. We greatly appreciate how he supports his suggestions with relevant documentation from the FDA, literature, or other credible sources, giving us...

Dr Karthik Raman

CEO | Persist AI, Woodland, CA, USA

3D Pharma Consulting Ltd