SPGL Limited

The FDA is exploring a risk-based approach to regulate the use of artificial intelligence (AI) in pharmaceutical manufacturing to improve efficiency, quality, and safety. Take a look at our article exploring the impacts and opportunities AI present in the industry here https://www.spgl.eu/navigating-the-future-fdas-exploration-of-ai-in-pharmaceutical-manufacturing-2/

Navigating the Future: FDA's Exploration of AI in Pharmaceutical Manufacturing - SPGL Background The US FDA has issued a discussion paper addressing the integration of artificial intelligence (AI) into the field of...

Comparative Efficacy Trials (CETs) have been a standard requirement in biosimilar development since the first biosimilar was approved in 2006. However, in recent years, there has been growing debate about the need for CETs, given the advances in analytical technology and our deeper understanding of structural activity relationships.

In our latest blog, Dr Layal Lutfi delves deeper into the insights gained at the recent FDA workshop on this hot topic. Read more here https://www.spgl.eu/re-evaluating-comparative-efficacy-trials-in-biosimilar-development/

Re-evaluating Comparative Efficacy Trials in Biosimilar Development - SPGL Background In recent years, exciting advancements in biosimilars assay technology have led to a deeper comprehension of structural activity relationships....

We had a blast, making memories for a lifetime. Can't wait until we get together again! A huge thank you to everyone.

Bon voyage! Nous sommes en route pour la France! We can't wait to celebrate 15 years of SPGL with all our colleagues.

The FDA recently released draft guidance on diversity in clinical trials. In this blog post, Dr. Layal Lutfi, Director of Regulatory Consulting and Compliance at SPGL ,discusses the key takeaways from the guidance and how they can help researchers design more inclusive trials. Click here https://www.spgl.eu/embracing-diversity-in-clinical-trials-insights-into-draft-fda-guidance/ to read more on this fascinating subject.

Embracing Diversity in Clinical Trials: Insights into Draft FDA Guidance - SPGL Background Despite widespread understanding and acknowledgement of diversity shortcomings among clinical trials, persistent difficulties exist. This issue is highlighted in...

Explore the FDA's proposed guidelines on Decentralized Clinical Trials with SPGL's GCP and Regulatory Compliance expert, Dr Layal Lutfi. Read her unmissable insight here https://www.spgl.eu/draft-guidance-for-decentralised-clinical-trials/

Draft Guidance for Decentralised Clinical Trials - SPGL Background The FDA’s draft guidance offers recommendations to sponsors, investigators, and stakeholders on implementing Decentralised Clinical Trials (DCTs) for drugs,...

Post Pandemic the EMA, EC & the HMA are phasing out Regulatory Flexibilities, read the must-see article: "Phasing Out COVID-19 Regulatory Flexibilities: Ensuring a Smooth Transition." here https://www.spgl.eu/phasing-out-covid-19-regulatory-flexibilities-ensuring-a-smooth-transition/

Phasing Out COVID-19 Regulatory Flexibilities: Ensuring a Smooth Transition - SPGL Background Amidst the COVID-19 pandemic, extraordinary regulatory flexibilities were introduced for medicines, effectively tackling regulatory and supply challenges. These flexibilities...

The UK government has updated its guidance for virtual manufacturing of medical devices, extending the acceptance period for CE marked devices in the Great British market beyond June 30, 2023. Read more on this development here https://www.spgl.eu/updated-guidance-for-virtual-manufacturing-of-medical-devices/

Revised Guidance for Virtual Manufacturing of Medical Devices - SPGL Introduction Being a manufacturer in today’s world doesn’t necessarily require physical production. In the medical device industry, companies often outsource...

Promising results emerge from the first-in-human study of a new Marburg vaccine. Read more here: https://www.spgl.eu/promising-results-emerge-from-first-in-human-study-of-marburg-vaccine/

Promising Results Emerge from First-in-Human Study of Marburg Vaccine - SPGL Introduction The global emphasis on vaccination since the Covid-19 outbreak in 2020 has underscored the importance of acquiring immunity to...

Discover why our graduate chose SPGL and read their inspiring journey here https://www.spgl.eu/graduates-introduction-to-spgl/. If you’re Interested in exciting opportunities at SPGL, Contact us now.

Graduates Introduction to SPGL - SPGL Finding SPGL Upon graduating as a Bioscience Engineer in August 2022, my exploration of opportunities in the Pharmaceutical Industry began....

Great to see our team supporting SISK to build, commission & qualify Janssens's new Car-T facility in Ghent, Belgium.

Wishing you all a Happy Easter from the SPGL team!

A toast to 2023 and a fantastic start to the New Year. A wonderful evening and great to see the team again! A huge thanks to Boothuys for hosting the event.

Breakthroughs in Advanced Therapy Medicinal products (ATMPs) are revolutionizing the health care industry!
But what exactly are ATMPs and how are the regulated? In our blog we take a closer look at this exciting new therapy, click below to read more.

An Overview of ATMP Regulation and Classification - SPGL What Exactly Are ATMPs and How Are They Classified & Regulated? Advanced therapy medicinal products (ATMPs) including breakthrough cell and...

What an incredible and celebratory evening with our team in Antwerp, it was a Christmas party to remember! A big thank you to everyone who made it a success. Looking forward to seeing you all in 2023!

A fantastic evening with our Belgian colleagues, Project Management training followed by food & drinks and World Cup football.

Last week our UK team attended the ISPE United Kingdom Affiliate Ltd Annual Conference & Awards Dinner held at the New Dock Hall, part of the Royal Armouries Museum in Leeds.
It was a fantastic black-tie event and great to see our fellow professionals, colleagues & friends working in the Life Sciences industry.

We are deeply saddened by the passing of Her Majesty Queen Elizabeth II. She was an inspiration throughout the globe and her impact during a lifetime of duty and public service was truly remarkable. Throughout her long and historic reign, she led with integrity, compassion and selflessness.
We express our heartfelt condolences to the Royal Family at this extremely sad and difficult time.

With our growing portfolio of projects, we urgently need to expand our team with highly capable Project & Quality Engineers, Scientists and Consultants. Join our team today! www.spgl.eu/careers

A funtastic and memorable afternoon learning to play golf while reconnecting with our international team. We enjoyed a golf initiation course at Golf And Business Club Kampenhout as well as a dinner party. Now begins the planning for our next event, looking forward to seeing you all soon!

Milan Swolfs Photography

In December 2021, a draft revision to ICHQ9 Guideline for “Quality Risk Management (QRM) in the GMP environment” was issued. The guideline included several new areas such as Subjectivity, Risk-based Decision Making and Supply Chain Complexity. The EMA has just published the comments made on the draft revision by an Expert Working Committee. Click the link here for detailshttps://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-guideline-q9-r1-quality-risk-management-ema/chmp/ich/24235/2006_en.pdf

Back to business as usual! After almost 2 years of remote working, our UK & European management teams met F2F in London. Two fantastic days of workshops, global strategy and good fun!

Looking forward to our next event this summer in Antwerp!'

Wishing you all a Happy Easter from the SPGL team!

“All that I am, or ever hope to be, I owe to my mother.” —Abraham Lincoln.
Happy Mother's Day from all of us at SPGL.