Picture of inhaler and tablets

The Team

We are based in UK and Switzerland, and can provide support across Europe. We have worked with some of the world's leading companies including GlaxoSmithKline, Roche, Sandoz, Reckitt Beckiser.

Paul

With over 20 years'experience in manufacturing and Technology Transfer Paul specialises in New Product Introduction and Launch, and provides the key link between R&D and Manufacturing. He has launched a number of high-profile products into new markets including dry-powder inhalers for the treatment of asthma, paediatric cough medicines, drug-delivery systems and is currently working on novel Auto Injectors for the delivery of Biologicals in pre-filled syringes.

As an enthusiastic supporter of flexible manufacturing he has developed on-line printing for packaging and tablets, and small-scale blister packers for niche products and personalised medicines.

He regularly delivers conferences in Quality by Design, and training in Six Sigma and Lean Manufacturing.

Roger

A Six Sigma Black Belt With over 16 years'experience in Pharmaceutical manufacturing, including Technical, Laboratory and Quality functions. Roger has built Proof of Concept manufacturing facilities, completed Technology Transfer and manufactured material for Clinical Trials. He led Transfers including API and Biological manufacturing in UK, Latin America, and Africa, and is currently working with clients in UK and USA.

He has implemented Quality Management Systems, and prepared sites for successful audits with FDA, MHRA, ANVISA and ISO, often at short notice.

He is a qualified IRCA Lead Auditor for ISO 9001:2008 and 13485, and is skilled in the management of 3rd parties, CMOs, distribution centres and contract laboratories.

Pip

An experienced Project Manager Pip has launched new Pharmaceutical products delivering over $5bn per year. She led the Transfer of a major manufacturing facility for sale to a 3rd party, including untangling embedded IT systems and defining new Service Level Agreements. She is particulary skilled in interfacing between customer and provider to define User Requirement Specifications and Functional Specifications to ensure that all deliverables are clearly understood and met.

A qualified Statistician she is equally at home identifying and delivering process improvements, and driving process capability as well as setting up new manufacturing operations and teams.

Mike

Mike has set up manufacturing operations in UK, Jordan, Malaysia, and across Europe and the Middle East. He has built new sites, set up joint ventures with local companies, carried out due diligence and transferred manufacturing knowledge and procedures. He recruited and trained local engineering teams and production staff from scratch, developed maintenance and calibration schedules, and put in place robust systems to ensure safety, quality and regulatory compliance.

A highly skilled mechanical engineer Mike also runs our prototyping workshop to produce models for marketing, customer feedback, handling trials and line set-up.

Paul
Roger
Pip
Mike