Pharmatrend GmbH Services Overview

Pharmatrend GmbH, Switzerland
GMP / GDP Services
© 2015 Pharmatrend GmbH
Who we are …
Founded beginning of 2010 by Bruno Keller, Owner and General
Manager, Pharmatrend GmbH offers a specific range of services
in the field of quality management for the pharmaceutical,
medicinal and related industries – mainly focussing on GMP and
GDP.
Pharmatrend GmbH acts as an independent service provider,
offering wide experience, profound competence and a wellestablished network.
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© 2015 Pharmatrend GmbH
Who we are …
CV Bruno Keller, Founder and Owner of Pharmatrend GmbH
1983 – 1986
1992
1992 – 1995
1995 – 2009
Since 2010
Professional Education: Chemist
A-Level Certification
Studies of Medicine (pre clinical), University of Zürich
International pharmaceutical company
(API, finished product forms, sterile production)
Consulting Agency Pharmatrend GmbH
 Post-graduate courses in pharmaceutical quality management
 Representative for GMP and Validation/Qualification
 GMP-inspections worldwide
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© 2015 Pharmatrend GmbH
Excurse Swiss Pharmaceutical Sector
 Ca. 1’300 licenced companies by Swiss Health Authority:
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A
B
C
D
E
Production
Importation
Distribution inside Switzerland
Exportation
Trading outside Switzerland
 Regularly inspections by the Health Authority Swissmedic
 Qualified Person (QP):
 Licences B to E: External person can be assigned (mandate)
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© 2015 Pharmatrend GmbH
Our Quality Management Services
 Quality Management
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Documentation in conformity with GxP-regulations
Validation / Qualification
Auditing, Inspections
Training
 Qualified Person (mandatary)
 For companies with licence B to E
 Regulatory Services
 Submission / Life cycle management of a Product
 Submission holder (e.g. for companies outside of Switzerland)
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© 2015 Pharmatrend GmbH
Our GDP Services
 Pharmalogistics (GDP, GSP)
 Planning and conception of
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Transport and flow of goods
Rooms and storage
Safety and entry systems
Storage and monitoring
Hygiene and pest control
Documentation
Validation / Qualification
Training
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© 2015 Pharmatrend GmbH
For further information please contact:
Pharmatrend GmbH
Industriestrasse 6
CH-9220 Bischofszell TG
Switzerland
Phone:
+41 (0)71 420 96 80
Fax:
+41 (0)71 420 96 79
[email protected]
www.pharma-trend.ch
© 2015 Pharmatrend GmbH