Discover our expertise

The pharmaceutical industry is one of the most complex industries, involving multiple stakeholders and processes. From the discovery of novel drugs through the clinical trials and approval process to market authorization, ensuring regulatory compliance is critical.

Regulatory Affairs is an essential function within pharmaceutical companies, where it plays a vital role in ensuring safe and effective medicines reach patients. This function includes managing the entire lifecycle of a medicine from discovery to marketing authorization, including post-marketing surveillance and vigilance.

ProductLife Group offers comprehensive solutions for pharmaceutical companies looking to streamline their operations and maximize efficiency. We help our clients navigate the complex landscape of pharmaceutical regulation, working closely with them to ensure that their products receive timely approvals and meet strict regulatory requirements.

We help pharmaceutical, biotechnology, and healthcare organizations develop their drugs, biologics, devices, and other medical products through innovation and global regulatory services.

Services

Product Development:

Our product development offerings guide you through all phases –  from early-stage development to initial approval and market introduction. We provide strategic advice and operational support for regulatory, scientific (CMC, clinical, non-clinical), and medico-economic activities.

Life Cycle:

Our integrated services cover all stages in life cycle management, from regulatory affairs and operations, safety, and vigilance to quality and manufacturing compliance.

Strategy & Digital:

As the advisory division of ProductLife Group, PLG Consulting provides strategic and digital consulting services. Our goal is to empower our clients with valuable insights to facilitate informed decision-making and ensure optimal implementation of those decisions.

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" EU Orphan medicinal products: legal framework, trends and lessons learnt "

An online event

30 april 2024

15:00

" Coming up 2024 ISPE 𝗘𝘂𝗿𝗼𝗽𝗲 𝗔𝗻𝗻𝘂𝗮𝗹 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 "

A live event in Lisbon

16 april 2024 - 18 april 2024

" Harmonizing Global and Local: the Benefits of Strategic Regulatory Outsourcing at Different Levels "

An online event

16 may 2024

16:00