In theory there is no difference between theory and practice… but in practice there is!

My name is Richard Smalley. I am the Managing Director and Principal Consultant for Vital Boost Limited. Having worked for over 30 years in the Pharmaceutical, Drug Substance / API (both large and small molecule), Excipient and Medical Device industries I gained a wealth of practical, technical experience as well as developing effective skills as a Qualified Person, senior manager, director and regional/global head of Quality. I decided in mid-2014 to take the plunge and start my own company in order to utilise these skills, my knowledge and experience in supporting companies who are in need of help. By giving myself fresh challenges I was thereby creating the opportunity to continue to develop and grow. Another contributory factor was the wish to locate our home nearer to our grown-up children and have more quality time to spend with them.

My latest projects include:

• IMP and commercial QP for "Luxturna" (RPE65) first AAV gene therapy approved in the US (now being launched).
• Commerical QP for Replixa- the worlds first aseptically spray dried biologic pharmaceutical.
• IMP and commercial QP for "Kymriah"- the first FDA- approved Gene Therapy (B-Cell ALL).

 

During my career I have worked in

• Quality Control and Development Laboratories,
• Production,
• Customer facing roles,
• Quality System Management
• Developed Vendor Assurance / Supplier Quality Assurance to eventually become Global Quality Head
• Acted as Qualified Person for parenteral products, solid dose, liquid, creams/ointments, inhalation products, transdermal patches
• Headed Corporate Compliance and Auditing, including being an expert auditor
• Supported successful pre-approval inspections for approximately 10 products
• Remediation of poorly performing sites (Compliance Management and/or IAG) but also including regaining ISO13485 and CE marking
• Implementation and development of Risk Management strategies at several different companies
• Provided strong leadership, motivated and rebuilt depleted and poorly managed teams to higher levels of efficiency and productivity
• Been a QP Assessor on behalf of the Royal Society of Chemistry for 6 years
• Presented in UK, Europe, US and Far East and issued papers on Risk Management, QP issues and Cold Chain

 

Vital Boost and its associates are different because of our unique blend of technical skills, knowledge, management experience and our effective, pragmatic approach to addressing problems and challenges.

 

As a regional and global head of quality in a number of different multi-national health science companies, I had need of short term support and consultancy services on a regular basis. I have been determined to offer services that deliver exactly what the client needs and add as much value in the process as possible. Our rates are competitive, but we aim to deliver more than our competition for what we are paid. We strive to be as flexible as possible but this is on the basis of a foundation of being highly organised, professional and efficient. The intent and what we continue to achieve is a reputation which results in growth by recommendations and repeat work with existing clients.

 

"Quality is not an act. It is a habit"- Aristotle.