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Whitepapers

Clinical investigations under MDR: Key insights and practical experiences

Achieving Laboratory Compliance

Innovations in ATMP: State of the industry in 2024

Ensuring compliance and quality in Pharmacovigilance

Organic and Mutagenic Impurities in Pharma

Standards and Regulations for Software used in Medical Devices

IVDR Extension: What does this mean for you?

Clinical Evidence for IVDs under IVDR

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Mobile Health on the Rise: Exploring the Regulatory Landscape for Reimbursement

The One Vigilance Strategic Roadmap to corporate excellence

The key role of RA in pharma: from drug development to commercialization

New GMP Facility Qualification: Set-up, Process and Best Practices

State-of-the-art literature review: Kick Off the Clinical Evaluation of your Medical Device

Clinical Evaluation for medical devices under the Medical Device Regulation

Medical Devices: The Pathway from Idea to Patient under MDR

EU GMP: How to import your products into the EU?

ICH Stability Studies on Pharmaceuticals: the latest guidelines and methods

Digital Health - Exploring the landscape and future opportunities

From V-model to Agile

A complete guide to Computer System Validation (CSV)

GAMP categories for computerized systems: what are they and what are they for?

Cell by Design: Why a practical framework is key to the R&D process of any cell-based ATMP

Analytical method validation: A validated process control method to determine cell density

Data integrity in the pharmaceutical industry

Mobile applications and compliancy

Technology Transfer Needs a Lingua Franca

Technology transfer: trends, facts and succes factors

Quality by design methodology in the pharmaceutical industry:n what, why and how?

A critical look at Annex 1: Manufacture of Sterile Medicinal Products

Checklists

Checklist 21 CFR Part 11: does your system comply?

Checklist Eudralex Volume 4 Annex 11

Compliance checklist ISO 13485:2016

Document checklist ISO 13485:2016 implementation

Checklist MDR implementation

Flyers

A quality-focused process development roadmap for ATMPs

QbD, your partner in medical devices

QbD, your partner in great quality management

Regulatory Affairs for Pharma and Biotech

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From Paper to Practice: Technical Documentation Essentials for Medical Device Software

Business & Communications

Webinar on demand - From Paper to Practice: Technical Documentation Essentials for Medical Device Software

Webinar (4)

Webinar on demand - Drug-Device Combination Products and Article 117

Webinar (3)

Webinar on demand - Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical investigations under MDR

Quality Assurance, Regulatory Affairs

Clinical investigations under MDR

Webinar (2)

Webinar on demand - From Requirements to Code: Streamlining Your Medical Device Software Development Cycle

From Paper to Practice: Technical Documentation Essentials for Medical Device Software

Business & Communications

Webinar on demand - From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

Webinar MDSW: intro

Webinar on demand - Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Achieving Laboratory Compliance

Quality Assurance, Regulatory Affairs

Achieving Laboratory Compliance

CPHI Milan

CPHI 2024 MILANO

Whitepaper social image

Quality Assurance, Regulatory Affairs

Innovations in ATMP: State of the Industry in 2024

One Vigiliance - ensuring compliance and quality in pharmacovigilance (1)

Quality Assurance

Organic and Mutagenic Impurities in Pharma

ONE Vigilance Ensuring Compliance and Quality in Pharmacovigilance

Ensuring compliance and quality in Pharmacovigilance

Standards-and-Regulations-for-Software-Used-in-Medical-Devices---QbD-Group

Software, Solutions & Services

Standards and regulations for Software used in Medical Devices

Whitepaper social image

Regulatory Affairs

Clinical Evidence for In Vitro Diagnostics under IVDR

webinar - ivdr extension

webinar on demand - IVDR Extension Explained: Tips & Strategies

Whitepaper social image-IVDR

IVDR Extension: What does this mean for you?

Global Compliance Free wp

Software, Solutions & Services

GAMP 5 Software Validation Approach for GMP, GCP, and GLP regulations

Next-generation Bio-Pharmacovigilance The ONE-VIGILANCE Strategic Roadmap to Corporate Excellence - V02 (1)

The One Vigilance Strategic Roadmap to corporate excellence