+44 141 582 1235

Kinesys has strong business support, regulatory affairs and product
development functions. Our product development knowledge
is diverse and has been utilized by Pharma and Biotech
companies alike to make a difference to their projects.
Our Board of advisors is available to assist our clients.

Kinesys’ Directors and Senior Consultants, have held senior posts in Pharma, Biotech and Medtech companies, in Regulatory Affairs, Clinical Development and Business Development. Kinesys has a Board of Advisors comprising top-level business people, academics, physicians and regulatory professionals. Our contacts with leaders in pharma and biotech companies, and with regulators, is second to none.
We have held Board positions in different biotech and medtech companies.

How we can help you

Management Consultancy & Business Acumen

Every week we see similar and fundamental questions arising amongst our client base:

  • Is the company set up adequately to achieve its goals?
  • What are the needs of the organisation going forward – financial, human resources, and technical expertise?
  • Do the plans fit the budget and address cash flow?
  • Will the development programmes and regulatory strategies achieve the business objectives?

We have set up, run and sold businesses, and represent several others at Board level. The management team members are able to effectively combine our product development, regulatory and business skills to help drive your business forward. We advise companies at the crucial regulatory phases of product development and approval, including appeals at Regulatory Agencies. We can provide Non-Executive Directors with a range of experiences in pharma and biotech companies. We can also assist with funding of start up and spin out companies.

Regulatory Affairs & Development Strategy

We can help you find answers to the big and the frustrating but often important small questions that arise in your regulatory and development strategies. Our experience of larger pharma and SME companies helps us to understand the broader challenges facing large organisations as well as the needs of the smaller, developing companies:

  • What is the best regulatory strategy to realise your business aims?
  • How do development studies dovetail with value inflexion points?
  • What will regulatory agency expectations be for your products and where are the likely pitfalls and major challenges?
  • Is your development strategy consistent with your business imperatives?
  • Design of development programmes and specific nonclinical and clinical studies.
  • Selection of CROs to conduct studies from Phase 1 to Phase 3.
  • “Hands-on” operational Regulatory Affairs and Clinical / Medical support.

Therapeutic & Product Development Experience

Our expertise extends to most drug therapeutic areas. The Directors, Senior Consultants and Board of Advisors have all worked on the development and registration of innovative and important new therapies in the areas of, for example, oncology, immunology, metabolic diseases, CNS and anti-infectives.

Our expertise extends to a wide range of NCEs, recombinant therapies, cell therapies and stem cell agents, and certain re-profiled products. Our clients include some of the largest Pharma and Biotech companies as well as innovative start up firms.

We have also worked on combination products involving drugs and devices and complex tissue engineered products.

Board of Advisors

The company’s Board of Advisors is composed of senior academics, experienced industrialists, regulatory experts and successful entrepreneurs. The Board of Advisors has been selected to bring together difficult-to-find, specialist knowledge and expertise from respected individuals. Our Experts, Directors and Senior Consultants work together, often representing clients and supporting their positions in negotiations with prospective business partners and with EMA, FDA and other regulatory authorities. This approach frequently makes the difference in securing the optimum outcome for our clients. Give us a call to discuss who can help with specific issues or questions.