PharmaLex US

This is a must-read!

// New! Read the eBook from subject-matter expert Gerardo Gomez, Ph.D. from regulatory consultancy PharmaLex which provides insight into key concepts in aseptic processing and current trends in their application, including special considerations for aseptic processing of ATMPs.

pharmalex.com

In this eBook, Gerardo offers valuable impressions on commissioning, qualification, and validation (CQV) from the 2023 Society for Pharmaceutical Engineers (ISPE) Aseptic Conference in Bethesda, MD. The meeting convened presenters and delegates from the world over to discuss recommendations for aseptic-process simulation (APS), novel isolator and restricted-access barrier (RABS) systems, implications of the 2022 update to Annex 1 of the EU good manufacturing practice (GMP) guideline, and more. Read the eBook now to learn about key concepts in aseptic processing and current trends in their application, including special considerations for the aseptic processing of ATMPs.

https://bioprocessintl.com/multimedia/ebooks/ebook-aseptic-processing-reflections-from-the-2023-ispe-aseptic-conference/

Book a meeting with Gerardo to explore your Quality, Management, and Compliance (QMC) projects today!

[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2" rel="ugc" target="_blank">https://outlook.office365.com/owa/calendar/[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2

// Exciting News! Our recent "Optimizing Product Development" event in collaboration with PA Biotechnology Center was a resounding success thanks to all of you who attended and contributed to the insightful discussions.

In an ever-evolving landscape, where innovation is key, it's crucial to stay at the forefront of product development strategies.

Our experts shared insights on how to avoid delays, streamline development, and improve the probability of success throughout each phase of the product development value chain.

Keep the conversation going! Let's continue to learn, grow, and optimize product development together.

// Are you losing sleep over product development challenges? Join us for a game-changing event, proudly sponsored by PharmaLex and hosted at the PA Biotechnology Center that will put your mind at ease!

Date: September 13, 2023

Time: 4:00 PM – 6:00 PM

Location: PA Biotechnology Center, Doylestown, PA

Register here: https://go.pharmalex.com/optimizing-product-development

The vast majority of drugs that enter development fail, most often during the clinical stages. Even at the earliest stages, successful product developers have an understanding of what it takes to progress their assets through development to regulatory approval and commercial success. Importantly this includes a keen awareness of the risks and challenges that can occur throughout the development lifecycle. Understanding those challenges and proactively planning for how to address them will reduce costs, save significant development time and improve the probability of regulatory and commercial success.

Join us to learn more about how to efficiently navigate the product development landscape.

This event is brought to you by PharmaLex, a leading consultancy in the life sciences industry, in partnership with the PA Biotechnology Center, a hub for innovation and research.

Learn more about PharmaLex: https://www.pharmalex.com/pharmalex-solutions/

// Unlocking Success in Regulatory Meetings: Check out Mark Lane, Ph.D.'s latest article on the "Top 10 Considerations when Meeting with Regulators."

Proper preparation is crucial for regulatory meetings, as it clarifies the necessary requirements and helps regulators grasp the development program and potential challenges.

These meetings go beyond gathering feedback; they foster strong relationships that streamline the drug development process. By understanding regulators' needs and timelines, you can achieve alignment, maximizing the chances of success.

Read the article here: https://www.pharmtech.com/view/top-10-considerations-when-meeting-with-regulators

Learn more about Integrated Product Development at PharmaLex: https://www.pharmalex.com/pharmalex-solutions/integrated-product-development/