Regulatory Consultants to the Biopharmaceutical Industry

Welcome

BCEU is a consultancy established to meet the requirements of smaller healthcare companies by providing expert support and advice in product development and commercialisation.

BCEU is focused on serving clients by adding value to their product portfolios and to their companies.

BCEU has wide expertise in regulatory aspects topics from many years experience in the pharmaceutical industry.

Areas of expertise include clinical trial initiation and mantainance, scientific advice and orphan designation procedures The group has particular knowledge in the areas of biotechnology and advanced therapies.

About BCEU

BCEU is a consultancy established to meet the requirements of smaller healthcare companies by providing expert support and advice in product development and commercialisation.

BCEU offers consulting services in all aspects of product development and commercialisation for the healthcare industry.

BCEU is a company whose ethos is driven by quality in all areas of activity and is focused on serving clients by adding value to their product portfolios and to their companies.

BCEU's advantage

What distinguishes BCEU from other advisors you could choose to support your development programmes?

Our depth and quality of experience and expertise
Our broad-based approach to product development and commercialisation
Our total commitment to quality
Our affiliations which provide expert local knowledge of regulatory practices in the USA
Our ability to add value to product development programmes
Our flexibility in offering a wide ranging service from an on-call regulatory advice through to overall project management responsibility for product development and commercialisation
Our ability to manage the interfaces between research, technical and commercial functions

The Team

Angus Cameron

Angus has over 35 years experience in contract research and pharmaceutical manufacturing. His manufacturing and regulatory experience includes blood products, small and large volume parenterals, transfusion and dialysis equipment. His experience in contract research has included overall programme management for numerous new products from small synthetic chemicals to complex proteins manufactured in animal cell lines and in bacterial fermentation systems.

Regulatory experience has included clinical trial application and marketing authorisation applications in Europe in a wide range of therapeutic areas with extensive experience of interacting with the regulatory agencies.

Peter Cooper

Peter has over 40 years experience in the global pharmaceutical industry. He has been involved in the successful development and commercialisation of more than 60 medicinal products in many therapeutic areas. One of his major contributions to successful development and commercialisation programmes is managing the interfaces between the different disciplines and functional areas involved.

He has held Director level appointments in Regulatory Affairs and Product Development in several major pharmaceutical companies with responsibility for European Development and Regulatory Strategies, the establishment of Joint Ventures with Regional Health Authorities and collaborative research agreements with Academic Research Groups. He has performed Due Diligence for both product and corporate acquisitions and for partnering.

Karen Walker

Karen has over 25 years experience in areas such as embryology and transgenic animal technology. She has worked in a number of drug development companies and CROs and been involved in planning and instigating clinical trial start-up and offering regulatory consultancy throughout the lifetime of trials. She has particular experience in cellular and other advanced therapies.

Ann Scott

Ann has over 20 years experience in regulatory affairs obtained in the pharmaceutical industry and within CROs. She has worked in the areas of orphan product designation, clinical trial applications and marketing authorisations. Her background is in molecular biology and she has experience with small molecules, biological and biotechnology products.