RegDev, Inc.

Thank you Brian Farnan for taking the time to chat with us about your passion for quality and compliance and what drew you to joining the RegDev team! #regdev #gmpsupport #qualityandcompliance

Did you know that RegDev has consultants based throughout the U.S., Europe, and Asia? Global presence is critical for several reasons:   🌍 Navigating Global Regulatory Landscapes  RegDev specializes in guiding clients through complex, region-specific regulations, ensuring compliance with agencies like the FDA, EMA, and MHRA.    🤝 Local Expertise and Relationships  Our strong relationships with regulatory authorities streamline interactions and reduce delays.    ⏱ Faster Time to Market  By harnessing local insights, we help clients accelerate drug development and approvals.    🌐 Supporting and Syncing Global Strategies and Trials  We help align regulatory strategies across markets, global clinical trials, and product submissions.    📈 Accessing Emerging Markets  We guide clients into high-growth global markets, overcoming unique regulatory hurdles. ⚠ Mitigating Risks  We help clients foresee and manage regulatory risks across diverse regions.  Unlock new opportunities -- partner with RegDev to navigate global regulatory landscapes. #regdev #global #regulatoryaffairs #inspectionreadiness #drugdevelopment

Join RegDev in Making a Difference! This fall we've partnered with One Warm Coat to host a virtual coat drive. One Warm Coat’s mission is simple: to provide free coats to children and adults in need while promoting environmental sustainability and volunteerism.  Over the past 30 years, they’ve collected 8.3 million coats and kept 21 million pounds of clothing out of landfills.   We’re encouraging our team members to find a local coat drive in their community on One Warm Coat's website. Let’s work together to make sure no one faces the cold without a warm coat. Spread warmth, one coat at a time! #RegDev #OneWarmCoat #GiveWarmth #SocialResponsibility #Sustainability #RegDevCares 

🚨 Your TMF is critical – don't make these common mistakes! 🚨   The TMF plays a crucial role in the success of studies, yet we see repeated errors that lead to delayed timelines, non-compliance, and increased costs.  Some of the most common pitfalls include:  ⚠ Delayed engagement of experts  ⚠ Inconsistent operational plans  ⚠ Filing errors  ⚠ Insufficient training and reviews  ⚠ Lack of understanding of submissions and approvals processes Avoid these common setbacks to reduce costs and avoid compliance risks.  Check out our latest article on common TMF mistakes and keeping it inspection ready to learn more: https://lnkd.in/gSB8YKHy #RegDev #Compliance #ClinicalResearch #TMF #ClinicalTrials 

At RegDev, “Your Vision. Our Innovation.” is more than a tagline— it’s the way we approach drug development. We go beyond just hitting milestones, focusing on long-term success through innovation, strategic problem-solving, and partnership. Here’s what sets us apart: 🖋 A Strategic, Tailored Approach  We align with your team from day one, using a risk-based approach to address immediate challenges while preparing you for future success. 🤝 Collaboration at Every Stage  From preclinical phases to regulatory approvals, we integrate seamlessly with your team, providing support and foresight through every milestone. 🎓 Empowering Your Team Through Education  We don’t just solve problems — we share knowledge, ensuring your team is prepared for evolving regulatory landscapes and future challenges. At RegDev, we’re proud to combine our core values of integrity, collaboration, and social responsibility with innovative strategies and solutions to help you achieve your vision.  Ready to redefine and improve your drug development journey? Get in touch to find out how we can work together to accomplish your goals.  #RegDev #YourVisionOurInnovation #DrugDevelopment #Collaboration #RegulatoryCompliance #LifeSciences #RegDevSuccess #Pharmaceutical #Biotech 

Regulatory Intelligence is the foundation of any organization's quality culture. How are you staying up-to-date? #regdev #regulatoryintelligence #gapassessment #biotechnology

Avoid costly errors and inconsistencies by developing solid SOPs.    SOPs save you time and money by providing a standardized approach to maintain regulatory compliance, verify trial and process integrity, prevent errors, enhance productivity, and ensure safety and efficacy.     Benefits of Working with RegDev for SOPs:    ✅ Improve Regulatory Compliance Essential for cGMP and GCP adherence.   ✅ Increase Consistency and Quality: Standardize processes and improve outcomes.   ✅ Enhance Employee Understanding: Foster a culture of quality and compliance.     RegDev’s Approach to SOPs    Our consultants begin with a gap assessment to evaluate and improve your SOPs. We integrate with your team’s operations to develop a customized compliance roadmap, leveraging our extensive SOP library.      Contact us to learn how RegDev can ensure your clinical and manufacturing practices meet the highest standards.       #RegDev #SOPs #RegulatoryCompliance #cGMP #GCP #ClinicalTrials #DrugDevelopment #GapAssessment   

Curious about how to work effectively with consultants? Here are five strategies we recommend for getting the most from your consulting engagements:  1️⃣ Identify Your Needs and Define Clear Objectives  Identify your challenges and set specific goals and outcomes before engaging a consultant.  2️⃣ Establish a Detailed Scope of Work and Role Responsibilities Clearly outline deliverables, timelines, and responsibilities to avoid misunderstandings or scope creep.  3️⃣ Onboard and Maintain Open Communication  Ensure proper onboarding, regular 1:1s, and open communication to keep everyone aligned. Onboarding also extends to the internal team, preparing them to work with consultants. 4️⃣ Be Open to Change  Be prepared to implement recommendations and secure team buy-in for successful outcomes. 5️⃣ Track the Metrics and Share Knowledge  Regularly track applicable metrics and ensure knowledge transfer for lasting improvements after the consultant's engagement ends. What strategies have you found most effective for maximizing the outcomes of your consulting engagements? Share in the comments and message us to learn more about how RegDev can help you achieve your goals. #RegDev #Consulting #Pharmaceutical #RegulatoryAffairs #TeamSuccess #RegDevInc 

Preparing for regulatory inspections can be daunting. Let RegDev's subject matter experts guide your team to success. Our SMEs ensure your clinical trials meet the highest standards, fostering a culture of compliance and quality. We strive to empower your team to confidently meet challenges, even after our engagement ends. The benefits of having a RegDev SME on your team include: ↘ Reduced risk of non-compliance and penalties  ✅ Improved patient safety and trial outcomes  📈 Increased efficiency in clinical trial processes  💪 Stronger relationships with regulatory authorities   Leverage our subject matter expertise to navigate regulatory challenges with confidence. Message us to learn more! #RegDev #InspectionReadiness #ClinicalTrials #RegulatoryCompliance #Pharmaceuticals

What are RegDev’s clients saying about the work we do? “Our company faced the challenge of bringing a potentially life-changing drug to market in a timely fashion. More specifically, we lacked expertise and resources for BIMO Readiness and PLI Audit Remediation activities. RegDev, Inc. was selected to provide their services and resources in both the US and Internationally. We also contracted RegDev, Inc for GCP and PV program activities over multiple projects by multiple sponsors. The outcome and benefits to our company resulted in a clean FDA PLI Inspection with no 483's. Their expertise and level of professionalism has been an invaluable endeavor.” -Colleen Hansen #clienttestimonial #regdev #inspectionreadiness #BIMOreadiness