With an average of over 12 years' per consultant, BioDesk offers its clients one of the most experienced and cohesive groups of regulatory, CMC and toxicology experts available across three continents.

Click on the position titles below for details on our team:

Dr Bryan Smith BioDesk Principal Medical Consultant

Dr Bryan Smith
is our Principal Medical Consultant and leads the Washington D.C. team. Dr Smith, a Family Medicine Clinician and Clinical Pharmacologist, has most recently served with the US Army Medical Materiel Development Activity (USAMMDA) where he chaired the multidisciplinary Integrated Product Teams and managed the development of products designed to prevent and treat malaria in the US Armed Forces. Previously, Dr Smith was a Fellow with the Walter Reed Army Institute of Research (WRAIR) Experimental Therapeutics, Dept. of Clinical Pharmacology and Assistant Chief, Department of Immunology and Medicine, Armed Forces Institute of Medical Sciences, in Bangkok, Thailand. 


Erik Doevendans, Owner and Consultant of BD-Consultancy B.V., is a Principal Consultant to CNS. Erik has 18 years industry experience with expertise in CMC and a background in quality assurance, control, medicinal assessment, regulatory affairs and manufacturing operations. Notably Erik was previously a Pharmaceutical Assessor at the Dutch Regulatory Authorities and an expert to the EMA.

martin Headshot 22Nov17 GIF

Dr Martin Moxham, BioDesk's Principal Consultant,
has over 24 years’ industry experience with particular expertise in EU regulatory strategy, clinical and non-clinical data evaluation and supporting scientific advice meetings. Previously Martin held the position of Director of Regulatory Affairs at Alkermes Pharma Ireland and was Managing Director at iRegulatory. Notably Martin is a TOPRA Fellow (FTOPRA).

MR headshot 27Oct

Mark Reid
, Owner and Consultant of Graythan Regulatory Services Pty Ltd., is a Principal Consultant to CNS. Mark manages NDA/MAA submissions for late phase oncology and anti-infective products and has a track record as a Virologist, Clinical Investigator and Senior Regulatory Affairs Manager in Europe and Australia, advising clients in pre-clinical and clinical planning for their NCEs and biologicals. He is a recognised expert in regulatory environments around the world for vaccines, gene therapy and genetically modified organisms (GMOs) and chairs CNS’ own Institutional Biosafety Committee (IBC).

Richard Turner

Dr Richard Turner
, BioDesk's Principal Consultant in the UK office, has been working in biopharmaceutical development for over 20 years. Richard is a former Pharmaceutical and Scientific Assessor at the Medicines Control Agency (now known as the UK MHRA) and has worked in senior regulatory positions in a number of biopharmaceutical development companies and consultancies including Daiichi Sankyo, Lonza Biologics, ERA Consulting, Elan and Antisoma.

Tracey Brown

Tracey Brown
, is a Senior Consultant with over 25 years’ experience in preclinical drug development, having worked as a Toxicology Study Director for 10 years and a Project Co-ordinator for over 10 years, responsible for the designing, implementing and interpretation of the toxicology packages required for a variety of clinical indications. Tracey has particular expertise in inhaled products developed while working in a large international pharmaceutical company. Tracey is a member of the British Toxicology Society (BTS) and the US Society of Toxicology (SOT).

Fedora Daye Feb17

Fedora Daye, is a Senior Consultant in the US office.  She has a BSc (Biology/Chemistry) and a MPH (Public Health) and has held a range of positions in research, consultancy and marketing in the health sector.  Since moving into Regulatory Affairs (RA) in 1998, she has held senior positions at Goldbelt Raven, Ioma Corporation and most recently as the Director RA at an International Partnership for Microbicides.  Fedora has extensive experience in program management and strategic advisory both internationally and locally with the US (FDA) regulatory authorities.

Caroline Dobbin BioDesk

Dr Caroline Dobbin, is a Senior Consultant and holds a PhD in immunology and parasitology.  She has experience in drug development and clinical trials, gaining over 12 years in the Australian and US biopharmaceutical sector.  Caroline has managed preclinical programs and provided medical writing, project management and scientific support for multiple early phase clinical studies in the therapeutic areas of infectious disease, rheumatology and respiratory medicine.  Her experience has included production of regulatory submissions to US and Australian regulatory authorities and the authoring of clinical protocols, Investigator’s Brochures and Clinical Study Reports in accordance with ICH guidelines.  Caroline joins CNS from the QIMR Berghofer Medical Research Institute where she held the position of Clinical Trials Project Manager and Medical Writer.

Simone Flight

Dr Simone Flight
, a Senior Regulatory Consultant within BioDesk, has worked for seven years in early drug development and eight years in the pharmaceutical industry including six years as a regulatory affairs consultant, consulting on international projects from early proof of concept, facilitating marketing authorisation approvals and coordinating post marketing activities. Simone has also worked for three years in RA and compliance within a multinational pharmaceutical company.

CNS HS 03 Louise


Louise Moore, is the Director of BioDesk Australia and has been with CNS for over eight years. Louise has more than 20 years’ experience in regulatory affairs and medical writing including nine years working for multinational pharma companies based in the UK and five years in a small Australian biotech, all involving liaison with US, European and Australian regulatory authorities.

Natalie Thomas

Dr Natalie Thomas
, is a Senior Consultant in the UK office. Natalie holds a PhD in biochemistry and molecular biology and started her career as a Research Scientist in the Australian pharmaceutical industry, prior to moving to the UK to commence work in regulatory affairs and product development. Natalie worked in consultancy and project management roles at ERA Consulting and Voisin Consulting prior to joining CNS, where she now provides EU, US and Australian regulatory support to clients. She currently sits on the Editorial Board of the regulatory professional journal, Regulatory Rapporteur, and has obtained the Regulatory Affairs Certification (EU) from the Regulatory Affairs Professional Society (RAPS).

Simon Bishop


Dr Simon Bishop, is a Consultant with over three years of experience and acts as the Project Manager/primary contact for a wide range of CNS clients. At CNS, Simon works on the full range of documentation/activities including protocols, Investigator’s Brochures and study reports, marketing authorisation applications and regulatory documentation regarding paediatrics and orphan drugs. Simon has a PhD in developmental neurobiology and previously worked for the Nature Publishing Group as an Editor of Scientific Literature.

Yadvindar Gill BioDesk

Dr Yadvinder Gill
, is a Consultant based in UK office and is focused on supporting clients with their product development and regulatory activities. Yadvinder holds a PhD in Cell Biology from University College London and has a PRINCE2 certification in project management. Prior to joining CNS, he worked at Mars as a Senior Research Scientist.  He has over six years of experience in developing innovative and commercially viable products.

Sara McSweeney

Sara McSweeney is a Consultant based in the UK with three years’ experience in managing drug discovery projects in international teams to deliver high quality solutions for unmet clinical needs. Sara has a PhD in Biological Sciences from the University of Edinburgh/UK and has previously worked as a research scientist at the National Heart & Lung Institute, Imperial College London and headed up the in vivo pharmacology team in the Cardiovascular and Metabolic Medicine (CVM) Group at Takeda Cambridge Ltd. At CNS, Sara is focused on providing product development and regulatory consulting support to clients.

Sally Yang BioDesk

Sally Yang
, is a Consultant with over two years of experience and acts as the Project Manager/primary contact for a wide range of CNS clients. At CNS, Sally works on the full range of US FDA regulatory and scientific/technical activities. Sally has a MS in clinical and regulatory affairs and holds a Regulatory Affairs Certification (US) from the Regulatory Affairs Professional Society.

Kelly Burns Associate Consultant


Kelly Burns is an Associate Consultant with two years’ experience on early phase clinical studies in the therapeutic areas of infectious disease, respiratory disease, haematology and immunological disorders.  Kelly started her career as a research scientist in reproductive biology in Newcastle Upon Tyne, UK and worked in skin pathology and histology before joining CNS where she now works as a medical writer. 

 Amy Cooke

Amy Cooke is an Associate Consultant based in the UK office and is responsible for supporting the creation of a range of documents for clients. Amy holds a BSc (Hons) Biomedical Science and MSc Cancer Biology from the University of Kent and is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and Royal Society of Biology.