Regulatory Solutions

  • Regulatory Solutions
  • Dossier Management
  • Product Safety
  • Cosmetics

Preparation of long term archiving of documents

Having to cope with the increasing size of their archives and the obligation of long-term storage of certain sensitive documents, pharmaceutical companies are becoming interested in the electronic archiving of documents and the storage of their paper documents under the best possible conditions..

BPO of an administrative process: Contracts management

Complete outsourcing of the overall administrative management and accounting processes for a national coordination service newly created in the perspective to manage multiple contracts and related obligations.

Change management: Preparation of documents and dossiers for regulatory submissions

To adapt the business process and tools to comply with Regulatory Submission regulation updates and to increase document preparation and management efficiency.

Regulatory Affairs: Data Quality Management

The marketing of medicinal products in over 100 countries involves a rigorous und updated follow-up of the global Regulatory Affairs activity.

Electronic Laboratory notebooks

Opportunity to implement electronic Laboratory notebooks.

eCTD : into an EDMS

Introducing eCTD format helped the global document management evolution.

Variations: management in international context

Preparation of an important number of variations dossiers in an in-sourcing configuration on the Customer site.

Managing the development projects portfolio of an R&D organisation

How an integrated resource management and project management system allows better allocation of resources and activities within the R&D Department.

Data management: analysis and extraction of data

Achieving compliance with the European Pediatric Regulation requires the compilation of the pediatric effects described in the marketing authorizations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force.

Document management: installation of validated platform

How to define and launch a global EDMS, starting from the R&Dís EDMS.

Latest News

ProductLife Group Expands German Operations with Acquisition of Kohne Pharma.
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Tuesday 17.06.2014
17-18 June Biomedia 2014 in Masstricht, Netherlands
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Thursday 12.06.2014
ProductLife Groupís Kohne Pharma celebrates 40 year anniversary
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Wednesday 04.06.2014
Getting Ready for the PSMF
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