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Whitepapers

Digital Health - Exploring the landscape and future opportunities

ICH Stability Studies on Pharmaceuticals: the latest guidelines and methods

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

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?

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

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

Mobile applications and compliancy

MDR 2017/745: a brief introduction

IVDR 2017/746 - How to prepare for compliance?

Data integrity in the pharmaceutical industry

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

Technology Transfer Needs a Lingua Franca

Technology transfer: trends, facts and succes factors

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

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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