Regulatory Solutions

  • Regulatory Solutions
  • Dossier Management
  • Product Safety
  • Cosmetics

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.

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.

Variations: management in international context

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

eCTD : into an EDMS

Introducing eCTD format helped the global document management evolution.

Electronic Laboratory notebooks

Opportunity to implement electronic Laboratory notebooks.

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.

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.

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.

Document management: installation of validated platform

How to define and launch a global EDMS, starting from the R&D’s EDMS.

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..

Latest News

ProductLife Group Expands German Operations with Acquisition of Kohne Pharma.
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Tuesday 02.12.2014
2–3 December 2014, Drug Information Association 15th Conference on European Electronic Document Management (eDM), Berlin
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Thursday 13.11.2014
13 November, PLG Evolve Webinar: Enhancing the Affiliate Relationship through Strategic Approaches to RIM
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Friday 31.10.2014
31 October, PLG Evolve Webinar and Petit Déjeuner: Industry Trends and Developments on RIM
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