ProductLife Group

ProductLife Group (PLG) is a consulting and outsourcing group of about 1,750 experts that pairs senior human expertise with intelligent automation across the product lifecycle: product development, engineering, market and patient access, product compliance, and digital and innovation. Its main offerings include pharmacovigilance outsourcing, computer system and process validation, HTA and market access strategy, and regulatory submissions and platforms.

Pharmacovigilance and Safety Operations

• Manage pharmacovigilance across the product lifecycle through case processing, signal management, periodic safety reports, local safety representation, QPPV services, PSMF management, and safety agreements, plus medical information services with up to 24/7 coverage. ProductLife Group can provide end-to-end pharmacovigilance outsourcing or support specific parts of a PV system.
• Handle safety intake and review through adverse-event and ADR download and triage, ICSR data entry, quality control, medical review, and submissions to EVWEB, MHRA, and USFDA. D.AI.M.I., PLG's proprietary modular AI ecosystem, speeds regulatory intelligence and submission readiness, with modules such as PV Case Intake.

Validation, Quality and Inspection Readiness

• Validate computerized systems across management, production-control, and laboratory applications, and establish data-integrity programs covering policies, training, and system controls.
• Prepare teams and facilities for inspections through PAI readiness, CAPA remediation, supplier qualification, audit preparation, QMS design and implementation, equipment qualification, and process and cleaning validation.

Market Access and Regulatory Submissions

• Develop market access and launch plans, patient-journey research, payer and reimbursement strategies, HTA submissions, health-economic models, and evidence plans for reimbursement decisions.
• Prepare regulatory content and submissions, including CTD Module 3 and quality overall summary authoring, marketing-authorization lifecycle submissions, regulatory strategy, agency meeting coordination, eCTD publishing, EU marketing authorization holder and US agent services, and regulatory platform implementation and migration.

Clinical Development, Evidence and Enterprise

• Support clinical programs with protocol design and endpoint selection, clinical project management, monitoring, data management, vendor oversight, biometrics functional support, and trial master file setup and maintenance. In Italy and Spain it acts as a full-service CRO, from first-in-human studies to post-approval phases.
• Provide broader evidence and operating-model support through comparative effectiveness research, real-world evidence strategy and analytics, data governance, custom AI and data-science development, business development and licensing, and transformation planning.

Best Fit

• Best suited to pharmaceutical, biotechnology, medical device, and other life-sciences teams needing outsourced pharmacovigilance, quality and validation support, regulatory operations, market access strategy, or clinical-development services.
• It also fits organizations preparing for inspections, generating reimbursement evidence, implementing regulated platforms, or managing regulatory and safety work across multiple markets.