Services platform
eCTD: Outsourcing in practice
Outsourcing of Regulatory Dossiers
ProductLife’s specialists in regulatory dossiers management offer their services for producing and maintaining your regulatory submissions in all formats (eCTD, NeeS and Paper), in accordance with the current regulations. All types of regulatory activities are covered.
Our technical and functional skills as well as our significant long term experience with major as well as small and mid-size pharmaceutical companies, enable us to guarantee the acceptance of your submissions by the Health Authorities without any technical objection. The whole process can be outsourced or insourced according to your needs and constraints.
By way of example, ProductLife Group was one of the first service partners to have successfully produced an eCTD submission in Switzerland for one of its clients at the beginning of January 2010.
We offer you a range of services adapted to your specific needs, from digitization with OCR of paper documents to lifecycle management of your eCTD submissions.
You will also directly benefit from:
- The experience of our Business Process Outsourcing (BPO) branch in the organization of such type of missions
- The expertise of our consulting branch which can act on any needs and issues related to regulatory submissions.
Thus, ProductLife Group can provide its clients with more than just a simple service of document production. Actually, ProductLife can define a real customized strategy based on three complementary axis:
- Full outsourcing (work totally realized by ProductLife out of the Client’s site)
- Insourcing with one ProductLife Group's team ((work totally realized by ProductLife on the Client’s site)
- Outsourcing and insourcing (a tailored mix).
The chosen strategy is based on the analysis of your company strategy, the nature of your product portfolio and the eCTD compliance of your documentation.
Moreover, ProductLife Group provides you with its "Publishing" and eCTD expertise regarding:
- Training services
- The ins and outs of the eCTD requirements
- The impact analysis on internal organization and company processes.
Organization of a mission
A mission can be represented by the diagram hereafter:
Technically, the production of a dossier consists in a sequence of two phases:
- Ensuring compliance of the source documents
- Producing the dossier as it will be submitted to the regulatory authorities.
The service is defined by two main elements:
- The terms of document and information exchange: in order to speed up the exchanges, we offer a safe and secure space on our servers ( FTP access) for exchanging documents. However, we can equally use an client's own resources (FTP, eRoom,...)
- Shared Anticipated milestones for:
1. Delivery pre-defined source documents groups (for instance a whole full 3.2.s)
2. Delivery last source documents
3. Deadline for submission delivery.
A dedicated key contact person from ProductLife Group is defined in order to propose a methodological framework ensuring the follow-up and success of the mission.
Outsourcing advantages
- To avoid the purchase and maintenance of expensive tools
- To avoid the training of employees, whose daily activity and expertise are not the production of eCTD/NeeS format dossiers
- To take advantage of ProductLife Group's global experience, built on a large clients base and their different types of submissions.
Our Values
- Commitment on delays and quality
- Reactivity
- Availability
- Client satisfaction.
Latest News
Monday 26.03.2012
Exhibition in Copenhagen: Join us at the 24th DIA Euromeeting
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Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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