Makena McGowan’s Post

- Eng: Here at Pint, Compliance is not negotiable! - Esp: Aquí en Pint, el Compliance no es negociable! - Por: Aqui na Pint, Compliance não é negociável! #compliance #compliant #weareallcomploance #complianceweek #somospint #viemosparasomar #wearepint

Discover what a career at our Manufacturing site may look like! Explore this article to gain insights into the enriching experience of working at Biogen and our cutting-edge manufacturing facility."

As the complexity of drug-device combination products increases, so do the regulations surrounding them. Are you confident in your ability to appropriately explain your new device to regulators? This Drug Development & Delivery editorial from our Vice President, Regulatory Affairs, Nicholas Smalley, provides valuable tips for advocating for your products. https://lnkd.in/dmejdnVA #drugdiscovery #drugdevelopment #pMDI

Accomplished first step to the Drug Development Product Management Specialization...

Customer-centric approach together with a skilled and experienced team always remains the main priority in managing projects. At Polpharma CMO we care about every detail to provide customized services. Each Customer is taken care of by a dedicated Business Manager who leads the tech transfer and acts as a Key Account Manager throughout the Product lifecycle. #Polpharma #PolpharmaCMO #Manufacturing #ContractManufacturing

I'm excited to share that I have recently completed the course "Drug Regulatory Affairs SFDA System Explained. Saleh Bawazir shared his knowledge with us regarding this valuable subject. I would like to express my gratitude to him for his efforts! #DrugRegulatoryAffairs #SFDA #PharmaceuticalRegulations #PharmaceuticalIndustry

I see that the role of regulatory strategist has shifted considerably FROM ‘ensuring that drug development program is in line with regulatory expectations’ TO ‘utilizing knowledge in regulatory expectations to help developing efficient and robust drug development programs’. This is a big shift in mindset. Therefore, a comprehensive understanding of drug development is paramount to become successful as a regulatory strategist.

The Pharmatech ecosystem comprises four foundational knowledge areas of product development: Compliance, Product and Process Development, Regulatory Affairs, and Facilities and Capital Projects including Validation. Our subject matter experts (SMEs) have fully integrated knowledge across the drug and device development lifecycle. Sounds great, right? But what’s in it for you? Cost and time savings in addition to faster, better decision-making, smaller, nimbler teams, and reduced program risk. We provide support to our clients from design through commercial implementation. Learn more about how we can improve your outcomes in the year ahead. https://hubs.ly/Q02dH0Pk0

You know the FDA approves your product, but did you know it’s the compendia organizations that dictate your therapeutic class? It’s a critical piece of your launch strategy, and we’re so grateful to have the expertise of our VP of Compendia Alisha Nielsen to help our clients. Our latest blog covers all the basics your launch plan should include, including compendia! https://bit.ly/3r2RHtM