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Global Life Sciences (LS - Pharma, Biotech, Medical Devices) to eHealth
Offering Vision/Strategy services in the field of International Conference on Harmonization (ICH) standards, regional regulations, including the Food and Drug Administration (FDA), European Medicinal Evaluation Agency (EMEA) etc. and Risk Management (RM) of non-compliance, including submission types like: eLabeling (PIM, SPL), Pharmacovigilance (PV); Drug Safety Reporting (ADR, ICSR etc.), and eDiscovery, leading to an Enterprise Information Strategy and Architecture. These activities are grouped within programs like eCTDMOVE, eCTDPLUS and contentMAX Competence Center, as well as in the eHealth holistic approach team: Aiming for effectiveness, consistency, transparency, interoperability.
Why do we qualify? 
Life Sciences
Consulting Partners (LSCP)
is a global network, founded in March 2004 as spin-off of a Regulatory Compliance (RC) organization formed over past years. Subject Matter Experts (SME) as to overriding ICH Standards like eCTD with long term experience in diver’s disciplines of the industry, including generics, as well as in major top global consulting firms have joined.
We have provided Thought Leadership and facilitation of events/processes in R&D, PV, RM, RC and beyond. We have gained extensive experience in top down approaches to reach consistency across functions and beyond. We developed and applied relevant methodologies: Collectively there are more then 390 p/y of experience at your disposal.
Our network of qualified SMEs, such as Medical Writing (e.g. Labeling starting point), Drug Safety Knowledge- and Change Management (CM) enables us to provide competence in any customer desired/required discipline, to include Providers and Payers.
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We all know each other well through work done together in large,
global programs and projects, always dedicated to the LS industry. When you click on «Contact»
you might find names you are familiar with. Commercially we qualify as being privately owned.
Management Team and where are we geographically located?
Headquarters & EU
Ruedi F. Blattmann, Managing Partner, Uerikon/Zurich, Switzerland
Raymond C. Benoit, MD, Partner Provider/Patients, Niederweningen/Zurich
Matthias Nanzer, MBA, Partner CM & Org. Development, Geroldswil/Zurich
USA
Steve Scribner, eCTD Lead Partner US, Pinehurst, NC
Don Rosen, B.S., Partner, Staten Island, NY
James Averback, MIT, Partner DMS, Huntington, PA
Gavin Quinnies, Partner, Lead Quality, Milwaukee, WI.
Japan
Hitoshi Matsui, Associated Partner, CAC Corp., Toyko
Associated Partners:
Douglas E. May (EIA); Jim McKiernan (SC); Stephan Gens (EDM); Paul Willer (CM, Org.); Malcolm Barratt-Johnson, MD (Agencies)
«Contact»
provides you with further details and email addresses
of all Partners, Associate Partners and SMEs as we believe in open and transparent
communication.
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