21 february 2023
For a successful technology transfer project, a blend of technical knowledge and project management expertise is an important parameter.
PLG can help pharmaceutical companies with the preparation, implementation, and oversight of technology transfer activities to identify and mitigate any potential risk which could eventually become a bottleneck either during the technology transfer process and/or during the commercial launch of a product.
ProductLife Group (PLG) supports & accelerates your Innovations – Start-ups, Innovation players, are you listening?
The start-up boom over the past decade has shown the potential for innovation and disruption in the Medtech and Biotech segments. Be it biomolecules, gene and cell therapies, niche medical devices, or digital health technologies, every innovation has the potential to drastically improve the global burden of communicable and non-communicable diseases. PLG believes in the power of such impactful innovations by start-ups.
Having more than 20 years in delivering regulatory compliance services for the safe and effective use of medical solutions, ProductLife Group can support you in Tunisia in managing all your principal registration, clinical, CMC and pharmacovigilance activities related to the Tunisian regulation requirements.
On the heels of recent news of In-Person, Face-to-Face Formal Meetings with FDA restarting on February 13, 2023, critical agency feedback, gaps in your data, and developmental studies, beware! Meeting the FDA to gain approvals doesn’t have to be scary.
Here’s everything your company needs to know to survive its next FDA meeting when working on your next medical product launch.
The pharmaceutical industry is highly regulated, so the first thing to consider in the selection of a tool is its adherence to all regional regulations. Most pharmaceutical companies have a global footprint and thus the tool selected must support the needs of all markets.
Partnering with the correct vendor can make the difference between success and failure, between efficiency and inefficiency.
Clinical Study Reports (CSR) are integrated reports of clinical studies for therapeutic, prophylactic, or diagnostic agents conducted in human subjects and the most crucial documents resulting from clinical trials.
Keen to know which type of CSR fits your study and need support with CSR authoring/review? We can support you !
Excited to announce that ProductLife Group has received a Silver certification from Ecovadis for our outstanding CSR strategy and practices!
A huge shoutout to our dedicated employees and the CSR Committee for their hard work and commitment.
The GAMP5 Guide provides guidance for the life sciences industry to ensure compliant computerized systems that are fit for intended use in an efficient and effective manner. Pharma IT recently hosted Sion Wyn, editor of the guide, for an exclusive event highlighting the new GAMP5 Second Edition.
In this Insight, we recap the event and provide 3 Key Takeaways concerning Critical Thinking, Agile Methodology, and the Case for Quality.
Go to our Events to register
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