Syner-G BioPharma Group

2024 has been a banner year for Syner-G BioPharma Group, and we are deeply humbled by the recognition of our efforts to foster a workplace rooted in well-being, inclusivity, and connection. This year, we were named one of BioSpace's Best Places to Work for 2025 which celebrates our commitment to maintaining an inspiring culture and work environment for both our employees and clients. Our initiatives celebrating diversity, such as the International Women’s Month LinkedIn Campaign, earned finalist honors from both Boston Biotech Week and the Ragan Communications and PR Daily CSR & Diversity Awards. Our Mental Health Awareness Month programs, Walk to Well-being initiative, and our Making an Impact philanthropic efforts were recognized by the Ragan Video, Visual, and Virtual Awards and American HR Awards. We were also finalists for the Ragan Employee Communications Awards for inspiring employee engagement through programs like Morning Brew and Chat over Chai. We are proud to be named one of Colorado’s Healthiest Employers and a Workwell Massachusetts Healthiest Employers award winner for our Total Health and Wellbeing Programming. Additionally, Mployer rated our benefits in the top 80-100% among similar companies. These honors highlight our commitment to exceptional benefits and supporting the well-being and financial security of our employees and their families. While these accolades are meaningful, they are ultimately a reflection of our people, their hard work, passion, and commitment to fostering an inclusive and collaborative culture. As we look ahead to 2025, we remain inspired to continue making a difference for our team, partners, and community. Thank you to everyone, especially our employees, who helped make this year so special. Together, we’ve built something truly meaningful. #YearInReview #WorkplaceCulture #OneTeam #WeInspire

Navigating the complexities of oncology drug approvals just got faster. The FDA’s Real-Time Oncology Review (RTOR) program accelerates access to life-saving cancer treatments by streamlining the review process for oncology drugs and biologics. In our latest blog, Regulatory Consultant Avani Shah explores the program’s scope, benefits, and challenges, including how Syner-G BioPharma Group can support RTOR submissions through expert regulatory strategy and submission services. From document preparation to regulatory agency interactions, we’re here to help bring innovative treatments to market efficiently. Read the full blog: https://bit.ly/3OY4FkU #Oncology #DrugDevelopment #FDA #RTOR #Biopharma #RegulatoryAffairs

In today’s pharmaceutical industry, ensuring the quality and safety of raw materials is essential to delivering effective treatments. A risk-based approach provides a robust framework for compliance, product quality, and patient safety. Learn how strategic vendor management, tailored testing protocols, and regulatory alignment can elevate your manufacturing processes. Read the latest edition of Innovations in Biopharma to explore actionable insights and best practices. #BiopharmaInnovation #RiskManagement #PharmaQuality #RegulatoryCompliance

Syner-G BioPharma Group is on a mission to enhance human health by supporting our clients in bringing life-saving and life-enhancing products to patients. Our work spans critical phases of the drug discovery and approval process, delivering meaningful, real-world outcomes with a strategic, solutions-driven approach. We promote a culture of growth, learning, and recognition, empowering our team to achieve greatness in their careers while maintaining our global reputation as a leader in biopharma consulting. Ready to make a difference? Explore opportunities to join our team: https://bit.ly/4fl3FCN #LifeAtSynerG #BiopharmaCareers #OneTeam #WeInspire

Bringing life-saving therapies to market quickly requires expert guidance at every stage of development. Syner-G BioPharma Group’s CMC consultants help biopharma companies navigate the complexities of CMC to ensure quality, regulatory compliance, and efficiency. From preclinical development through regulatory submissions, we work alongside your team to address challenges early, optimize manufacturing processes, and reduce delays. Our tailored strategies keep your product development on track, helping you meet regulatory standards and deliver treatments to patients faster. Learn more about how we can accelerate your path to market: https://bit.ly/4eVtGrr #CMCConsulting #PharmaInnovation #DrugDevelopment #RegulatoryCompliance

With the U.S. Congress reviewing the Biosecure Act, concerns over clinical and commercial supply chains are intensifying, particularly as reshoring manufacturing gains momentum. Syner-G BioPharma Group supports these changes with: - Supplier Selection: Vetting labs and CDMOs - Tech Transfers: Seamless transfer plans - Skilled Expertise: Method development and formulation - Local Presence: “Person-in-plant” support in the U.S. and India Let’s connect to discuss streamlining your operations in response to these shifts: https://lnkd.in/eRAW_ewD #BiosecureAct #ClinicalSupplyChains #TechTransfer

Navigating the complexities of regulatory submissions requires expertise in Chemistry, Manufacturing, and Controls (CMC). Syner-G BioPharma Group's CMC consultants play a pivotal role in ensuring compliance, streamlining submissions, and accelerating time-to-market. From mitigating data gaps to aligning global submission strategies, our experts help biopharma companies meet stringent regulatory standards while positioning products for competitive success. Discover how CMC consultants can drive your product's success: https://bit.ly/3CWzofz #CMCConsultants #RegulatorySubmissions #PharmaInnovation #BiopharmaSolutions #FDACompliance

Syner-G BioPharma Group brings extensive experience in managing Project Orbis submissions, ensuring faster, coordinated approval pathways across international markets. Project Orbis, an FDA initiative, allows for concurrent review of oncology products across seven markets, giving cancer patients worldwide earlier access to critical treatments. Our regulatory experts have successfully guided numerous products through this streamlined approval process. Discover how Syner-G's solutions can help you successfully navigate Project Orbis: https://lnkd.in/gwSHuxFG #ProjectOrbis #Oncology #FDA #RegulatoryStrategy #BiopharmaInnovation

Syner-G BioPharma Group is proud to announce our attendance at the 43rd Annual JPM Healthcare Conference this January in San Francisco, CA. As a trusted partner in the biopharma industry, we provide comprehensive services in product development, regulatory strategy and submissions, functional outsourcing, medical writing, and quality and compliance. Through our integrated approach, we help clients navigate developmental challenges and the complexities of regulatory filings, ensuring timely, high-quality submissions that advance their pharmaceutical assets. Let’s connect at JPM 2025. Schedule a meeting with our experts to explore how Syner-G can support your success: https://lnkd.in/dUq7tAwF We look forward to contributing to the conversations shaping the future of healthcare innovation. #JPM2025 #Biopharma #LifeSciences #HealthcareInnovation

As we approach November, it's essential to proactively plan depot transfers and site shipments to ensure seamless patient dosing over the holiday period. Take the time to review your patient forecasts, upcoming maintenance requirements, and product expiry dates to accurately determine the material needed for transfer to depots. Planning for the period from November through the end of January can help mitigate potential disruptions in patient dosing. For sites where patients are scheduled for dosing during the holiday season, consider arranging a manual site shipment ahead of time to confirm that the Investigational Product (IP) is available on site. De-risking the supply chain during the holiday season is a best practice, offering assurance and operational continuity during the busy end-of-year period. Syner-G BioPharma Group is ready to provide comprehensive clinical supply management support for both ongoing and new clinical supply chain needs. Contact us to learn more about how we can assist. https://bit.ly/3Y9zJ5C #ClinicalTrials #SupplyChainManagement