Umetrics

Umetrics was founded by Professors Svante Wold and Rolf Carlson in 1987 as a spin-off company from Umeå University. From a modest start with two part time employees Umetrics has grown to a company with >50 employees and offices in Sweden, UK and US (west and east coast). Through MKS Instruments, that acquired Umetrics in 2006, Umetrics is also represented in Singapore and Japan.

Science

Professor Svante Wold, one of the founders of chemometrics, was for many years Umetrics Chief Scientific Officer and is now Senior Advisor. Professor Wolds most prominent student Associate Professor Johan Trygg works closely with Umetrics and the OPLS and O2PLS methodology, invented by Trygg, has been implemented in Umetrics software. Umetrics also has a number of PhDs employed that are frequent publishers of scientific papers as well as invited speakers at conferences in Design of Experiments (DoE) and Multivariate Analysis (MVA).

Consultancy

Umetrics consults for many pharmaceutical companies. As consultants we guide and/or perform the planning, execution, and report writing of studies under PAT or QbD. A number of these technical reports have then been used for submissions to authorities and Umetrics has been involved in answering questions.

Training

Umetrics has 20 years of experience from giving three day courses in DoE and MVA primarily to pharmaceutical companies. During the last 5-10 years training customized towards the introduction of DoE and MVA for persons involved in PAT and QbD has been developed. Such training has been given as part of EFPIA as well as EMEA activities and has included personnel from both these pharmaceutical associations. Umetrics has also given training seminars at MPA (Sweden) and IMB (Ireland) and FDA (US).

PAT and QbD

During the FDAs definition of "Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance", September 2004, and the subsequent definition of "Q8(R1) Pharmaceutical Development Revision 1", November 2007, Umetrics were involved as advisors as well as reviewers directly with FDA and as consultants to pharmaceutical companies.