Whitepapers

Whitepapers

IVDR 2017/746 - How to prepare for compliance?

MDR 2017/745: a brief introduction

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

Mobile applications and compliancy: what you should know

Data integrity in the pharmaceutical industry - a brief overview

Technology transfer

Technology Transfer Needs a Lingua Franca

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

Checklists

Checklist MDR implementation

Checklist ISO13485

Flyers

QbD, your partner in great quality management

QbD, your partner in medical devices

A quality-focused process development roadmap for ATMPs

Scientific papers

Single-cell transfection technologies: a brief introduction

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