Citeline Regulatory’s Post

When it comes to the drug development process, regulatory is one area that simply cannot be overlooked; there's too much is at stake. Citeline Regulatory's TrialScope Disclose ensures compliance every step of the way to clear the pathway to your success: https://ow.ly/GQsW50T8WHS.

Your development plans need to match your business goals. Whether your aim is an #NDA or #acquisition, right-sizing your asset development can make all the difference. Tune into the full session with Lisa Jenkins VanLuvanee of Facet Life Sciences to learn more about how to scale regulatory operations at the following link: https://lnkd.in/gPQKG4N4 #nda #regulatory #regulatoryoperations #regops #regulatoryaffairs #pharma #drugdevelopment #lifesciences #clinicaltrials #clinicalresearch #clinical #medtech #biotech #consulting #webinar

At Facet Life Sciences, we understand that meeting with the FDA isn't just a regulatory requirement—it's a critical business activity. Our team's expertise ensures Sponsors obtain clear guidance and achieve agreement on regulated product development needs. This not only reduces business risk but significantly boosts the probability of success in reaching regulatory milestones. Timely feedback is not just a regulatory benefit; it's a strategic advantage, resulting in more efficient development programs and substantial cost savings. Join us in reshaping the future of drug development. #FacetLifeSciences #BusinessStrategy #RegulatorySuccess #ToAndThroughFDA

Explore how quality and compliance can enhance every aspect of your drug development and manufacturing process. Read more about the difference between quality and compliance in our latest blog: https://hubs.ly/Q02sGkZ50 #drugdevelopment #compliance #pharma #Quality

How can you ensure the safety and integrity of your product? Analytical testing. 🧪 Not only is it critical for drug and product safety, but analytical testing can accelerate innovation and create a smooth regulatory review process. Need help outsourcing tests so you can focus on the core elements of your operation? Check the tests we offer here: https://azzur.co/3RPizI1 #Labs #Biotech #Pharma #DrugDevelopment

LET’S MEET & CHAT📣📣 Heading to RAPS Convergence in Long Beach, California, from September 17-19? Join Technolution and me (Lonnie Hjerrild Hedberg 😉) to connect and share nerdy insights on how to navigate the highly regulated MedTech and Pharma industries through regulatory affairs. Let’s set up a time to chat! #RAPSConvergence #MedTech #Pharma #RegulatoryAffairs

The FDA’s recently updated guidance on “Benefit-Risk Assessment for New Drug and Biological Products” represents a significant shift towards a more patient-centric approach. Staying ahead of regulatory changes like this one is crucial for success, which is why we've put together an article that explains: - What the guidance means for pharma companies - How to implement the guidance - Challenges and opportunities https://hubs.la/Q02N86d50 #FDA #Compliance

Knowing beats guessing, any day of the week! Do you doubt whether your product fits the market you are considering, or if it qualifies for reimbursement? The remedy is early market analysis. Gaining valuable market insights early in the development process will help you stay on the right path. This is the final part in our series of 5 costly pitfalls to avoid in drug development. Do you need support with clinical regulatory affairs? Let’s connect! contact@arexadvisor.com #regulatoryaffairs #clinicalreg #drugdevelopment #arexadvisor #pharma #marketaccess #earlyaccess

Process scale-up, validation, and technology transfer are crucial steps in drug development and manufacturing. Our website has the complete online training agenda for you to understand the challenges of scaling up a drug manufacturing process, the regulatory landscape behind the process validation, and performance measurement. You can get your copy now by following the link in the comments. #drugdevelopment #drugmanufacturing #scaleup #technologytransfer #onlinetraining #SymmetricTraining