Quality-by-Design(QbD)

Quality by design (QbD) is an approach that aims to ensure the quality of medicines by employing risk management, experimental and statistical methodology in the design, development and manufacturi

ISO 13485

ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international

The challenges of potency assay development for cell-based medicinal products in Europe

May, 2015
Regulatory Rapporteur

Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2

June, 2015

Regulatory Rapporteur

This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Modern Technology Transfer Strategies for Biopharmaceutical Companies

March, 2015
BioProcess International

An overview of the latest technology transfer strategies used by bio-pharmaceutical companies today.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 1

February, 2015

Regulatory Rapporteur

An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

European Medicines Agency (EMA)

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

European Directorate for the Quality of Medicines (EDQM)

The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities.

Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference on Harmonisation (ICH).

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