Reliant Life Sciences

Cleaning and sterilization shouldn’t stall innovation.    Across the life sciences, companies face growing complexity in sterilization requirements: • Guidance around sterility assurance levels, validation, and bioburden testing continues to shift. Falling behind even slightly can delay approvals.  • Novel delivery devices, combination products, and advanced therapies often demand sterilization methods beyond traditional steam or gamma irradiation. One size rarely fits all.  • Scaling processes from R&D to GMP manufacturing exposes gaps in cleaning validation, documentation, and staff expertise. These gaps can quickly escalate into compliance risks.  • Contract sterilizers, specialized materials, and limited in-house expertise make timelines vulnerable to external bottlenecks. Reliant Life Sciences can help. By partnering with Reliant, life science innovators gain on-demand access to specialized expertise without overextending internal teams, enabling them to build robust cleaning and sterilization strategies aligned with product and regulatory requirements.     Our flexible engagement models bridge talent and resource gaps quickly and efficiently, helping to de-risk audits and inspections while protecting development timelines. Close the gap between innovation and compliance by building a sterilization strategy that scales. Zachary Connelly can tell you how: zconnelly@reliantlifesciences.com  or 603-803-3118. https://lnkd.in/eBgPDX7r #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech 

There are few milestones as exciting - and as daunting - as a facility expansion.  Whether it’s building out new lab space, expanding a manufacturing suite, or establishing a second site, the move represents both opportunity and risk.  Done right, expansion accelerates innovation and positions a company for long-term growth. Done poorly, it can drain capital, stall programs, and create bottlenecks across teams. The challenges start early.  Hiring technical talent quickly enough to support new operations can feel impossible in today’s competitive market. Layer on the need for specialized expertise in regulatory compliance, validation, and quality systems, and even well-prepared companies risk costly delays.  Timelines often slip, budgets stretch, and critical programs may be put on hold while teams scramble to catch up.  You need more than headcount. You need expertise that grows with you. You need interim specialists that can keep your expansion project on track. This is where the right partner can completely change the game.  Reliant Life Sciences brings the talent and consulting expertise needed to keep expansions on track—from interim specialists to long-term hires, plus guidance on compliance, validation, and operational readiness. Facility expansion isn’t just about square footage—it’s about preparing an organization to operate at its next level. With the right talent and expertise in place, life science innovators can expand with confidence, knowing their people, processes, and programs are aligned for success. Scaling your space is just the start. Let’s build the team to match. Zachary Connelly can tell you how: zconnelly@reliantlifesciences.com  or 603-803-3118. https://lnkd.in/exezczVF #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech 

Be forewarned - when FDA “flexibility” feels like a free pass, it rarely is. Enforcement discretion gives temporary leeway—but missteps can stall programs, drain resources, and put credibility at risk. The smarter path? Treat it as breathing room, not a shortcut. Build compliance early, align your teams, and be ready when oversight tightens. That’s where partnering with the right experts can turn ambiguity into advantage—and keep your innovations on track.    At Reliant Life Sciences, we help life science innovators:  • Translate vague regulatory language into actionable steps.  • Scale up quality, regulatory, and clinical functions before they become bottlenecks.  • Protect investor confidence with a credible compliance roadmap.  • Turn uncertainty into a strategic advantage rather than a source of risk. Always remember: FDA enforcement discretion is not a shortcut—it’s an opportunity. The companies that recognize this, and prepare accordingly, are the ones that keep their programs on track and deliver therapies and devices without disruption. Don’t wait for enforcement discretion to expire. Schedule a free consultation with Zachary Connelly and protect your program’s momentum: zconnelly@reliantlifesciences.com  or 603-803-3118. https://lnkd.in/e2tEq3Q7 #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech 

Postmarket surveillance is critical to ensuring ongoing safety, efficacy, and regulatory compliance while driving continuous product improvement and patient trust. Many organizations face challenges managing complex postmarket surveillance and adverse event reporting, navigating evolving regulatory requirements across global markets, analyzing real-world evidence to inform lifecycle decisions, and coordinating cross-functional teams for timely responses and updates - issues that can delay corrective actions, increase risk, and ultimately impact commercial success. At Reliant Life Sciences, our staffing and consulting solutions provide the specialized expertise needed to: • Implement robust postmarket surveillance programs aligned with current regulations  • Deliver high-quality safety and risk management reporting  • Leverage real-world data for actionable insights  • Facilitate seamless communication between regulatory, clinical, and commercial teams Transform device approval into enduring impact. With the right talent in place, organizations can safeguard patients, mitigate risks, and maximize product value throughout its lifecycle. Ensure Compliance. Enhance Patient Safety. Turn Postmarket Challenges Into Opportunities. Zachary Connelly can tell you how: zconnelly@reliantlifesciences.com  or 603-803-3118. https://lnkd.in/er8FRnnV #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech 

Turning metabolic potential into progress requires more than advanced instruments—it demands specialized expertise at the right moment. From integrating metabolics with multi-omics programs to navigating rapid tech shifts and meeting evolving regulatory standards, talent gaps can stall innovation. We connect life science innovators with the scientific, technical, and regulatory minds who can: • Design and execute rigorous metabolomics studies.  • Translate complex data into actionable insights.  • Optimize workflows for speed, accuracy, and compliance. Metabolics isn’t just a research tool—it’s a competitive advantage. Let’s build the team that will help you seize it. Call Zachary Connelly today at 603-803-3118 to learn how Reliant can help you turn scientific potential into measurable progress.  https://lnkd.in/eq-Reiep #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech #cellandgeneediting 

Whether you’re developing next-generation vaccines, pioneering cell-based immunotherapies, or expanding diagnostic capabilities, success depends on having the right scientists, clinicians, and regulatory experts in place.     Yet today’s market makes finding and retaining this expertise a major challenge. As a result: • Critical projects are delayed because niche immunology expertise is hard to secure.  • Top candidates are being hired fast, often before companies can make an offer.  • Teams are stretched thin, leading to burnout, compliance risks, and missed milestones.  • Companies face uncertainty about how to rapidly staff up for Phase I/II trials or new immunotherapy programs. That’s where Reliant Life Sciences comes in. We connect you with the talent and consulting expertise to overcome these barriers—fast. From immunologists and clinical scientists to regulatory strategists and quality leaders, we build teams that enable you to keep your pipeline moving from discovery through clinical development. Because in immunology, the right expertise isn’t just an advantage—it’s the difference between leading the market and lagging behind.   Your next milestone is closer than you think. Make sure you have the right team in place.    Zachary Connelly is ready to help you secure the immunology talent your pipeline depends on. Give him a call at 603-803-3118 or zconnelly@reliantlifesciences.com    https://lnkd.in/evkp336G #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech #IND #investigationalnewdrug #drugs #drugdevelopment 

From regulatory frameworks to the latest industry insights, the #RAPSConvergence is where the world’s compliance leaders meet—and this year’s gathering in Pittsburgh, PA is shaping up to be one of the most dynamic yet. We’re talking 2,000+ global delegates from 6 continents and 37 countries—with 31% representing medical device manufacturing. The reach, diversity, and expertise in one place is unmatched. This year, our own Shawn Leo Hunsaker—a recognized voice in medical device compliance—will be on-site, ready to connect with peers, swap insights, and talk through the challenges and opportunities shaping the future of the industry. At Reliant Life Sciences, we believe big ideas deserve bold conversations (and great coffee). That’s why we’re proud to sponsor this year’s coffee break—because sometimes the best breakthroughs happen between sessions. Perk up your compliance game! Stop by for a cup, say hello to Shawn, and let’s explore how we can help your team achieve your regulatory goals.     Reliant is brewing compliant solutions, one cup at a time. https://lnkd.in/e9AJFupA #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech #RAPSConvergence 

Cell and gene editing is rewriting the future of medicine, but turning breakthrough science into real-world therapies is no simple task.   The greatest risk? Not having the right talent in place at the right time, because in cell and gene editing, talent isn’t just a resource - it’s the foundation of your success. Reliant Life Sciences can help. We connect biotech, medtech, and pharma companies with the expertise needed to accelerate cell and gene editing programs—without sacrificing quality or compliance.  Our network includes:  • Molecular biologists, immunologists, and process engineers to drive discovery and development.  • QA/QC leaders and CMC experts to ensure GMP manufacturing and analytical rigor.  • Regulatory affairs specialists experienced with ATMP submissions and global compliance.  • Clinical operations professionals to keep studies on track, from recruitment through data reporting.  • Risk management and pharmacovigilance experts to safeguard patient safety and program integrity. Don’t let talent gaps stall your breakthroughs. Connect with Zachary Connelly today to secure the expertise you need to turn today’s discovery into tomorrow’s therapy. He’s ready to take your call at  603-803-3118.  https://lnkd.in/eSrVVYF8 #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech #cellandgeneediting 

Now is the time to take your career to the next level. At Reliant Life Sciences, we don’t just match talent with opportunity—we help leading biotech and pharmaceutical organizations deliver groundbreaking therapies to patients faster. And today, we’re growing our own team. We’re actively seeking driven Business Development professionals who are ready to make an immediate impact in a rapidly evolving biotech and pharmaceutical landscape. In this role, you’ll: - Forge partnerships with top biotech, pharma, and medtech innovators  - Collaborate with a high-performing team dedicated to client success  - Lead strategic growth initiatives that accelerate scientific progress  -Thrive in an agile, entrepreneurial environment where your contributions matter from day one If you excel at building relationships, solving complex challenges, and driving meaningful growth—this is your moment. This is more than business development—your skills can help change lives. Start your journey with Reliant. Rick O'Callaghan is ready to talk next steps: ricko@reliantlifesciences.com https://lnkd.in/e-wXahD7 #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech #hiring #businessdevelopment 

The way you manage risk can determine whether your program advances or stalls. Regulatory inspections, clinical trial oversight, and supply chain complexity create constant pressure points. The stakes? Missed milestones, costly delays, and reputational damage that can set your organization back years. Common barriers include: • Meeting evolving requirements for QMSR, ISO 13485, ICH, and FDA guidance.  • Difficulty finding risk management professionals who understand both the science and compliance landscape.  • Quality, clinical, and regulatory teams working in isolation, leaving dangerous blind spots.  • Teams stretched too thin, resulting in reactive firefighting instead of proactive prevention. Reliant’s staffing and consulting solutions help you close these gaps before they compromise your progress. We provide: • Experienced quality and regulatory leaders who strengthen your risk posture.  • Frameworks aligned with ISO 14971 and FDA guidance to safeguard compliance.  • Cross-functional risk assessments that eliminate blind spots.  • Agile resourcing to support clinical development and manufacturing scale-up without slowing momentum. Put risk management at the center of your strategy, not on the sidelines. Give Zachary Connelly a call at 603-803-3118 and build a proactive risk culture that accelerates results.     https://lnkd.in/e4eapwHJ #FDA #regulatoryaffairs #lifesciences #pharma #biotech #compliance #qualitymanagement #medicaldevices #qualityassurance #documentation #staffing #consulting #postmarket #medtech #riskmanagement