"If I am looking at a more global combination product program, how are things different between the United States regulation and other territories?" "What should I be aware of as I enter various territories?" "What should I consider when developing a global regulatory strategy for my drug delivery device system?" These are common questions we hear from clients who are exploring global markets. If you are considering a multi-territory approach to your combination product, check out answers to these questions in our ever-growing "How to build a successful combination product program" article: https://lnkd.in/guD3z4Vs #globalregulatorystrategy #regulatoryaffairs #combinationproduct #drugdeliverysystem #deliverydevice #medtech #pharma #biotech
Suttons Creek’s Post
More Relevant Posts
-
Getting the right team in place is critical to drug delivery device development success. Check out this article for human resources-related answers to the most common questions we hear from your industry colleagues. And keep checking back weekly as we expand topics!
What types of expertise, roles and responsibilities should your combination product team have? Visit our quick-read article to find out: https://lnkd.in/gPJ4NMCG #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #outsourcing #humanresourcing #devicedevelopment #medicaldevice
To view or add a comment, sign in
-
As a Life Sciences company, you know how important a Batch Manufacturing Record is. This written document outlines the entire drug manufacturing process. It is comparable to the “prototype” of a drug as it includes its name, the weight and amounts of its components, the procedures to be followed in its production, its shelf life and storage conditions, to mention just a few of its aspects. Need to learn more or considering how to manage it? it can be a hassle free and smooth process if you leave it to us: 👉 https://bit.ly/3fXORAC We have you covered! #BRM #pharma #regulatory #lifesciences
To view or add a comment, sign in
-
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
To view or add a comment, sign in
-
Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards. Learn about the importance of component specifications when selecting packaging for your drug product needs here: https://bit.ly/3VbJgcr #PharmaceuticalPackaging #HighQuality #QualitybyDesign
To view or add a comment, sign in
-
You face the challenge of ensuring that particulate, endotoxin/pyrogen and bioburden contamination is adequately controlled in your aseptic filling?🧐🤔 Get in touch with us now 👉 www.dedecke-gmbh.de/en #primarypackaging #biologics #cellandgenetherapies #drugdevelopment #pharma #pharmaceuticalindustry #pharmaceuticals #biotech #pharmaceuticalmanufacturing #Pharmaindustry #Lyophilization #Biotechnology #healthcare #primarypackaginglovers
Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards. Learn about the importance of component specifications when selecting packaging for your drug product needs here: https://bit.ly/3VbJgcr #PharmaceuticalPackaging #HighQuality #QualitybyDesign
To view or add a comment, sign in
-
Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards. Learn about the importance of component specifications when selecting packaging for your drug product needs here: https://bit.ly/3VbJgcr #PharmaceuticalPackaging #HighQuality #QualitybyDesign
To view or add a comment, sign in
-
Vice President, Product Management, Elastomer and Container Closure Components at West Pharmaceutical Services
Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards. Learn about the importance of component specifications when selecting packaging for your drug product needs here: https://bit.ly/3VbJgcr #PharmaceuticalPackaging #HighQuality #QualitybyDesign
High Quality Packaging Solutions
To view or add a comment, sign in
-
Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards. Learn about the importance of component specifications when selecting packaging for your drug product needs here: https://bit.ly/3VbJgcr #PharmaceuticalPackaging #HighQuality #QualitybyDesign
High Quality Packaging Solutions
To view or add a comment, sign in
-
Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards. Learn about the importance of component specifications when selecting packaging for your drug product needs here: https://bit.ly/3VbJgcr #PharmaceuticalPackaging #HighQuality #QualitybyDesign
High Quality Packaging Solutions
To view or add a comment, sign in
1,585 followers