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