The Digital Application Dataset Integration: A Step Towards Better Data Management

It is increasingly important to have a robust Regulatory Information Management System (RIMS) in place to support the regulatory process through the streamlining of registration, data, and lifecycle management. As a first step towards the implementation of a RIMS, the European Medicines Agency’s Digital Application Dataset Integration (DADI) will replace the current PDF-based electronic forms (eAF) with a new web-based application to harmonize data management.

 

Find out more about DADI

With the Acquisition of Quoretex, PLG Strengthens its Capabilities in Quality and Compliance

After establishing operations in the USA, India and Czech Republic in 2021, ProductLife Group (PLG), a global leader in regulatory and compliance services for the life sciences industry, expands its quality and technical consulting capabilities with the acquisition of Quoretex.
Founded in 2018, Quoretex specializes in Quality management and Regulatory Compliance in Europe. Over the past 4 years, the company has developed a range of methods aimed at improving the quality practices within the pharmaceutical industry, reducing time to market and production stoppages.

 

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Compliance with the ICH Q12 Guideline - Pharmaceutical Product Lifecycle Management

ICH Q12 will give a thorough understanding of the Pharmaceutical Quality systems (PQS) for managing post-approval CMC changes and the potential regulatory advantage for certain post-approval changes. It allows the manufacturer to determine established conditions and efficiently manage post-approval changes through risk management. It is also intended to demonstrate how increased product and process knowledge can reduce the number of regulatory submissions, which will consequently reduce regulatory oversight prior to implementation.

 

Read more about the ICH Q12 Guideline

Adoption of EU variations guidelines by SAHPRA (South African Health Products Regulatory Authority)

In November 2019 the South African Health Products Regulatory Authority (SAHPRA) adopted the European Union’s (EU) guidelines to improve new product registrations and variation approvals. In the three years since the changes were introduced timelines have been dramatically reduced and companies are no longer having to wait years for their marketing authorizations to be approved.
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The Implementation of the EU Clinical Trial Regulation 536/2014

With the implementation of the EU Clinical Trial Regulation (536/2014), it is important for sponsors to be aware of the changes that will impact ongoing and upcoming Clinical Trials. ProductLife Group (PLG) offer clinical trial sponsors the knowledge and expertise required to successfully navigate this transition.

 

PLG Readability testing services

ELC Group, now part of ProductLife Group, has had proven success with readability tests, focus tests and bridging reports. Our experienced team follows the procedure set by the European Medicines Agency (EMA) and has the capacity to cover all types of submission procedures (Centralised, Mutual Recognition, Decentralised and National. We conduct testing across all therapeutic groups — from simple generic products to more complex biotechnology products. Our aim is to minimize the number of tests performed to expedite your approval process.
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June 2022 Monthly Newsletter