Kate Coleman’s Post

Do you want to assure a smooth path to market? It's all about Regulatory Strategy! Reach me out in case you want to discuss some ideas! Find out more below ⬇ #regulatory #strategy #consultancy

Is your drug product strategy missing a key piece? Our latest blog post, "The Importance of Integrating a Robust Regulatory Strategy Within Your Product Strategy," explores how a well-crafted plan can significantly improve your chances of success. Our Director of Regulatory Affairs Sandra Lourenço takes you through: * Why a siloed approach can hinder your product's journey * The benefits of a cross-functional regulatory strategy * How to navigate the development process with confidence Ready to ensure a smooth path to market?  Read the full blog here: https://lnkd.in/eCRq5S9X. This blog contains links to access our recent guide and a useful webinar. #regulatory #pharmaceuticals #pharma #biotech

DSI offers a wealth of resources, backed by decades of collective experience in drug product, drug substance, and combination product development and commercialization. Our experts provide comprehensive support that typically requires multiple contractors and consulting firms. Leverage our expertise to streamline your development and regulatory processes. Explore our regulatory resources here: here: https://bit.ly/3MGlEHw #DrugDevelopment #RegulatoryAffairs #Pharma #Biotech #CombinationProducts #Commercialization #DSI #Consulting #Pharmaceuticals #RegulatoryCompliance

Scaling your #pharma business in alignment with GxP across the board is a crucial challenge to consider; it’s one that technology can help with, making your growth profitable and secure. Find out how in our new blog: https://lnkd.in/eKx_4hSU #pharmaceuticals #biotech

[Upcoming Webinar] Join LighthouseAI on Thursday, September 19th for a live market research session titled “The State of State Licensing” where we will quantify the biggest problems in state licensing. Following the webinar, we’ll provide you with a comprehensive report presenting all of the collected data you can use to advocate for the support and resources you need to excel in your role. Register Today: https://lnkd.in/ejkGxdsp #LighthouseAI #Webinar #MarketResearch #StateLicensing #Compliance #Regulatory #Pharma #Pharmaceutical

Need help choosing a drug manufacturing partner? If your team is small, you might find it tough to navigate the many equipment options available—that's where our specialized expertise can make a big difference. Here's how we can help: 1) We identify necessary equipment for your production 2) We'll help evaluate your manufacturing partner options 3) We keep your future scale-up and regulatory changes in mind to ensure long-term efficiency Let's simplify your next steps. Connect with Tyne Jeffrey today! #Pharmaceuticals #Biotech #DrugManufacturing #CMO #CDMO #Pharmaphixx

Our panel of drug substance experts share critical insights on the declining number of API manufacturing professionals in the U.S.—a trend that could impact the future of the industry. Hear what they have to say: https://bit.ly/3ZQzn6n #Pharmaceuticals #DrugSubstance #APIManufacturing #PharmaIndustry #PharmaExperts #DrugDevelopment #Biotech #LifeSciences #PharmaTrends

Thanks to Bioprocess Online, Outsourced Pharma, and Biosimilar Development for running my recent piece on how recent draft guidance tells us how FDA is looking at post-approval changes for biosimilars and interchangeables. #FDA #pharmaceuticals #compliance #research #pharma #biotech #law https://lnkd.in/gYaKk6UE

Learn about the complexities of supply chain management and five best practices right here.

[Upcoming Webinar] Join LighthouseAI on Thursday, September 19th for a live market research session titled “The State of State Licensing” where we will quantify the biggest problems in state licensing. Following the webinar, we’ll provide you with a comprehensive report presenting all of the collected data you can use to advocate for the support and resources you need to excel in your role. Register Today: https://lnkd.in/ejkGxdsp #LighthouseAI #Webinar #MarketResearch #StateLicensing #Compliance #Regulatory #Pharma #Pharmaceutical