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Whitepapers

MDR 2017/745: a brief introduction

IVDR 2017/746 - How to prepare for compliance?

Mobile applications and compliancy: what you should know

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

Data integrity in the pharmaceutical industry - a brief overview

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

Technology Transfer Needs a Lingua Franca

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 by applying the analytical QbD approach

Checklists

Checklist MDR implementation

Guides

The Pathway from Idea to Patient

Flyers

A quality-focused process development roadmap for ATMPs

QbD, your partner in medical devices

QbD, your partner in great quality management

Scientific papers​

Single-cell transfection technologies: a brief introduction

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