SI Associates

SI Associates - International Life Sciences Management Consulting

SI Associates is an international management consulting company with its principal offices in Glasgow in the UK and in Cambridge, MA in the US. SI supports its global life sciences clients in improving their ability to design, develop, commercialise and manufacture safe and efficient products profitably.

LIFE SCIENCES: TIME-TO-MARKET REDUCTION, RISK MITIGATION AND PROFIT INCREASE

SI Associates’ expertise is in operations management. Its life sciences practice focuses on applying the top techniques to new product development and introduction,supply chain management, quality management and manufacturing.

Many of our areas of focus are now commonplace phrases in life sciences, which are being systemised in ICH Q8, ICH Q9 and ICH Q10. The skills with which we routinely equip our client partners include:

  • Quality by design
  • Design for manufacture
  • Lean manufacturing and six sigma
  • ISO 9000
  • Process Analytical Technologies (PAT)

OUR ALLIANCES WITH GLOBAL PHARMACEUTICAL LEADERS GET RESULTS

Of greater importance than the things that we do are the results we achieve through working together with our client teams. We work with the majority of the leading global pharmaceutical, biotech and device companies and together we achieve outstanding performance.

Some examples of these are:

  • Throughput improvements of 40% in the product optimisation and clinical materials management operations of a global pharmaceutical company
  • A 15% reduction in development cycle times with a US-based pharmaceutical company
  • In the case of a UK-based global pharmaceutical company, an 80% reduction in late stage development cycle times
  • 20% cost of sales reduction and 35% revenue increase with the European clinical supplies operation of a global CRO
  • 1,100% improvement in the CQA parameters of a medical device through to scale-up, ensuring successful registration and security of supply to market
  • Transforming Cpk values of a medical device in late stage development through to manufacture from less than 1.25 to 2.67, improving efficiency and yield
  • Improved process conformance for the key attribute of a solid dosage drug form in late stage development from 65% to 99.7%, enabling successful and timely scale-up
  • Implementing a process for the development, selection and implementation of PAT systems for a US-based global bio-tech leader ensuring compliant product and processes and improved overall equipment effectiveness

80% OF SI ASSOCIATES' NEW BUSINESS GENERATED FROM CLIENT REFERRALS

These results, and many like them, are achieved through cooperation with our clients. SI brings expertise from life sciences and from other technology-led sectors and applies this knowledge pragmatically and practically for the benefit of the client. Impressively, our client contacts form references for our services. Indeed some 80% of our new business is generated through referral from, or extensions within, our existing client base.

SI Associates combine academic achievement with outstanding track records in line management and consulting. We understand many of the operating challenges with which our clients and their people contend because we have faced similar challenges. If you would like to discuss the challenges you encounter in any areas that you require assistance, please get in touch.

SI Associates Ltd.
100 West Regent Street
Glasgow G2 2QD
United Kingdom
Tel: +44 0 141 332 5825
Fax: +44 0 141 332 7655
Email: info@siassociates.com
Email (Harry Clark, managing director): Harry_Clark@siassociates.com
URL: www.siassociates.com

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An internal orientation session on the ICH Q8 and ICH Q9 guidance documents for the SI marketing team.
An internal orientation session on the ICH Q8 and ICH Q9 guidance documents for the SI marketing team.
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Aligning the product to the process is the key not only to quality and to compliance but also to efficiency.
Aligning the product to the process is the key not only to quality and to compliance but also to efficiency.
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A fully characterised product is a non-negotiable requirement for safety.
A fully characterised product is a non-negotiable requirement for safety.
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Harry Clark is the managing director of SI Associates.
Harry Clark is the managing director of SI Associates.
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