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Productlife Group

Description: 

Services

Change Management/Implementation, Consulting, Document Management, Electronic Submissions Preparation, Medical Writing, Pharmacovigilance, Project Management, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation,. /quality assurance/control

Description

PRODUCTLIFE is a proven European provider of process and business services as well as consulting for Life Sciences companies. ProductLife's mission is to assist its Clients to adapt to regulatory changes and ever-increasing requirements for information exchange, especially regarding safety and efficacy, throughout the product lifecycle.


We focus on three main areas of intervention:

Regulatory services, documents and data management

Assistance for dossier preparation, production, submission and maintenance

Product safety management

Pro-active safety and pharmacovigilance

Quality and Industrial Risk Management

Quality

 

We offer three types of missions

Competitive advantages:

Highly qualified and rigorously selected human resources / Responsive approach to any needs and expectations / Security from gained experience / Strong commitment to results and zero-defect / Global or transversal project management capacity.

For more information, visit our website and/or take contact with your local office in France, Germany, Switzerland, Belgium and United Kingdom.

    • Assistance and support for choosing, validating, implementing and operating systems for data and electronic document management, dedicated to R&D and Regulatory Affairs
    • Process evaluation, optimization and adaptation for an increased operational efficacy
    • Regulatory databases management
    • Regulatory documentation and product information management
    • Regulatory operations management by delegation
    • Preparation for archiving
    • Assistance with optimizing/streamlining the company dossier preparation, publishing and maintenance processes (CTAs, CTDs, variations, baselines...)
    • Medical and scientific writing (CMC, clinical and non-clinical)
    • Dossier publishing and submission
    • Variations management in full outsourcing
    • Risk management planning
    • Production and implementation of risk management plans
    • Assistance in risk/benefit balance evaluation
    • Consultancy and medical advice
    • Introduction of signal detection processes and tools, bibliographic searches and PV management systems
    • PV database management, bibliographical searches and PV documentation and reports
    • Provision of EU Qualified Person(s) for Pharmacovigilance (QPPV)
    • Introduction of the Master Data Referential to streamline industrial and logistic processes all along the supply chain
    • Alignment of Quality Management system- and processes with regulatory requirements: assistance with ICH Q9/Q10 guidelines implementation
    • Raw materials suppliers qualification
    • Interactions between CMO/manufacturing sites and internal and external regulatory authorities
    • Preparation for audits and inspection
    • Interactions between corporate and production sites
    • A team of acknowledged Qualified Persons at your service
    • Quality Assurance support, training and coaching at all levels
    • Batch documentation review and batch release by a QP
    • Expertise and consulting
    • Services platform
    • Operational assistance

Services: 

Change Management/Implementation, Consulting, Document Management, Electronic Submissions Preparation, Medical Writing, Pharmacovigilance, Project Management, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation

Contact Information: 

Productlife Group
24 rue des Moulineaux
Suresnes, , 92150, FRA
Phone : 0141442211
Fax : 0147724755
Internet : www.productlife-group.com
Email : kspaepen@productlife-group.com
Contact Person : Katrin Spaepen