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Regulatory consulting and services

Regulated processes

eCTD submission, Dossier outsourcing

EDMS and IT solutions implementation

Quality assurance

Pro-active safety

 



 

"The commitment results of a long term relationship with our customers is a fundamental value of Product Life since its creation" (Pierre Cuny, CEO)

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Our service offering

The services offered by Product Life cover a wide area of expertise. The common thread linking these services is the support we provide to our clients in the Life Sciences sector in adapting their reglemented processes and cost structure to the changes taking place in their regulatory, societal and technological environment.


To cover this range of requirements, Product Life is composed of two complementary divisions:

  • The "Consulting and Expertise" division

  • The "processus outsourcing" division
     

Download our documentation

Processus Outsourcing - BPO

Since 1993, Product Life has specialised in the outsourcing of administrative and technical processes (business process outsourcing or BPO). Whether insourcing (at client sites) or outsourcing (from our technical centres), Product Life is unique in that all assignments are carried out in the form of projects, with a service solution tailored to fit each client issue, regardless of the client's size or sector. The project teams at Product Life undergo a rigorous selection process based on their professional experience and personal attributes.  Each team comprises industry experts with proven experience in the relevant sector. 

 

If you choose to outsource some or all of your technical and administrative processes to Product Life, you are guaranteed a customised service that is tailored to your needs and dedicated to achieving operational efficiencies within your company.

 

The following are examples of document-based processes and data procedures that can be outsourced:

  • Document management and preparation of dossiers for electronic submission: editing, formatting and publishing of CTDs, eCTD, both national and international in origin.
  • Update, migration and recovery of regulatory event databases 

  • Preparation of data for physical and electronic archiving
  • Medical and pharmaceutical editing, bibliographic research
  • Creation of templates and development of computer-aided editing tools
  • Management of contracts with third parties
  • Processing of documents: scanning, OCR, indexing

 

Our outsourcing assignments are systematically managed on the basis of the following:

  • Specific, quantified and measurable objectives in terms of expected results
  • Identification and compliance with constraints
  • Definition of a project plan at the outset
  • A schedule specifying, in particular, the start date and end date of an assignment.

 

Our approach is based on the following:

  • An understanding of our clients' objectives and constraints
  • Quantification of the expected results
  • Definition and quantification of the necessary tasks/resources
  • A clear, fixed commitment to achieve the agreed results 

 

Choosing the BPO expertise of Product Life to enhance the competitiveness of your company means that, above all, you will be using a trusted service provider capable of responding to your every need.

Focus

Outsourcing electronic submission filing: From strategy to training, from consultancy to services

Preparing to archive documents (long term)

Variations: treatment in international context

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