DISCOVER OUR SEGMENT GLP AND REGULATORY/ SCIENTIFIC ARCHIVING

Size: px

Start display at page:

Download "DISCOVER OUR SEGMENT GLP AND REGULATORY/ SCIENTIFIC ARCHIVING"

Damian Jenkins
8 years ago
Views:

1 DISCOVER OUR SEGMENT GLP AND REGULATORY/ SCIENTIFIC ARCHIVING

2 OUR FOCUS We offer a complete archiving concept for all regulatory needs (regulatory/scientific archiving and GLP-compliant storage). Our clients benefit from a European or global central archive that provides suitable, sufficient, and perfectly safe storage for all archive material. Our portfolio of tailor-made archiving services contains solutions for your regulatory and scientific archiving needs. Thanks to our own unique database system EDDMS (Electronic Document and Dossier Management System), we can ensure that all regulatory information is close at hand, wherever you are, including electronic documents and submission details. SCC can also be of assistance in securely archiving your GLP raw data in 2004, we were successfully certified as the first GLP contract archive in Germany.

Our portfolio of tailor-made archiving services contains solutions for your regulatory and scientific archiving needs.

3 GLP ARCHIVING SERVICES CERTIFIED BY THE GERMAN AUTHORITIES COMPLETE GLP-COMPLIANT ARCHIVING CONCEPT for all regulatory needs CENTRAL ARCHIVE European or worldwide GMS (GLP Archive Management System) developed, designed and proven as a valid GLP management system EXACT, IMMEDIATE AND EASY RETRIEVAL OF INDIVIDUAL UNITS of archived data and materials COMPLETE AUDIT TRAIL of all entries or changes of records guaranteed RISK ELIMINATION through regular back-ups of the database SECURITY MONITORING 24/7 SEPARATE CUSTOMER ARCHIVING AREA possible REVIEWS AND REEVALUATIONS of GLP study raw data by SCC scientists in response to inquiries from authorities

archived data and materials COMPLETE AUDIT TRAIL of all entries or changes of records guaranteed RISK ELIMINATION through regular back-ups of the database

4 REGULATORY ARCHIVING SERVICES EDDMS Our Electronic Document and Dossier Management System DEVELOPED AND DESIGNED BY SCC PROVEN AND TESTED OVER DECADES as our regulatory dossier management system SPECIALLY DEVELOPED INDEX SYSTEM DATA ARCHIVING AND RETRIEVAL SYSTEM that guarantees fast and reliable access to archived information VERSATILE TOOLS FOR DATA ADMINISTRATION, DATA PRESENTATION, TRACKING OF STUDIES AND REGULATORY SUBMISSIONS WORLDWIDE ELECTRONIC ACCESS TO ALL REGULATORY AND SCIENTIFIC INFORMATION for your active substances and products TIME- AND COST-SAVING COMPILATION OF REGULATORY SUBMISSIONS REFERENCE LIST GENERATION in any format for all authorities worldwide, and export of electronic files including Annex Point indication QUICK AND EASY GENERATION OF CADDY FORMAT DOSSIERS thanks to automatic import TASK FORCE SUPPORT customised access rights for different client users CALCULATION OF COST OF STUDIES AND COST COMPENSATION

TRACKING OF STUDIES AND REGULATORY SUBMISSIONS WORLDWIDE ELECTRONIC ACCESS TO ALL REGULATORY AND SCIENTIFIC INFORMATION for your active substances and products TIME- AND COST-SAVING COMPILATION OF

5 OUR EXPERTISE 25 YEARS OF ARCHIVING EXPERIENCE DIRECT INTERNAL GLP DATA REVIEWS POSSIBLE by SCC scientists for all areas CERTIFIED BY GERMAN AUTHORITIES AS THE FIRST GLP CONTRACT ARCHIVE since 2004 MORE THAN 20 YEARS EXPERIENCE in handling of GLP studies TASK FORCE SUPPORT Calculation of cost of studies and compensation, and support for multiple user needs HUNDREDS OF DOSSIER PREPARATIONS and international submissions FULLY EQUIPPED ARCHIVING FACILITIES according to official requirements

GLP studies TASK FORCE SUPPORT Calculation of cost of studies and compensation, and support for multiple user needs

6 OUR TEAM SCC Scientific Consulting Company was founded in 1989 by Dr Friedbert Pistel. During our 25-year history we have become one of Europe s largest privately owned and independent consulting companies, supporting global customers in the regulatory affairs business. SCC is headquartered in Germany in the culturally attractive Rhein-Nahe region and located in a modern building complex. The Global Office Japan was established in 2007 and the Global Office Berlin in Bad Kreuznach Berlin Tokyo 110 SCC employees 80% with a university degree in 15 different disciplines from 10 nations

7 SCC SCIENTIFIC CONSULTING COMPANY Chemisch-Wissenschaftliche Beratung GmbH HEADQUARTERS Christine Haas Manager Information Services/ GLP Archive Tel Fax Am Grenzgraben Bad Kreuznach Germany GLOBAL OFFICE JAPAN Kozo Inoue Director, GLP Archiving for Chemicals and Biocides Toshiyasu Takada Director, GLP Archiving for Agrochemicals and Biopesticides, Veterinary Medicine and Pharma Pre-Clinical 251 AR

de Am Grenzgraben 11 55545 Bad Kreuznach Germany GLOBAL OFFICE JAPAN Kozo Inoue Director, GLP Archiving for Chemicals and Biocides kozo.

Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement

Responsibilities of Test Facility Management & Sponsor Rik Hendriks Werner Coussement J&J R&DQA, Beerse, Belgium rhendrik@prdbe.jnj.com J&J GPCD, Beerse, Belgium wcoussem@prdbe.jnj.com Responsibilities