Premier IND/CTA and BLA/NDA Strategy, Submissions and Management Services

Navigating the initial submission for an Investigational New Drug (IND) application in the US or a Clinical Trial Authorization (CTA) in other regions is a critical step in clinical development and can start as early as with the pre-IND meeting. At Syner-G, we provide strategic planning that anticipates obstacles, mitigates as needed, and prepares documentation with the necessary content and submission services tailored to streamline this process. Our regulatory experts ensure that your IND/CTA not only meets all regulatory requirements but also adheres to specific in-country requirements and leverages core global documents, enhancing alignment with your clinical strategy for maximum efficiency and success. This comprehensive approach helps facilitate timely approvals and ensures a cohesive regulatory strategy across all jurisdictions involved in your clinical trials.

Beyond the submission, maintaining your IND/CTA is vital for continued compliance, managing changing clinical needs, supply chain implications, and strategic progress. At Syner-G, our services extend to managing annual reports, updates to regulatory documents, amendments in response to trial modifications and/or process changes, and active management of communications with regulatory authorities. Additionally, we conduct thorough gap assessments and risk mitigation evaluations to preemptively address potential challenges. We also develop strategic regulatory roadmaps that navigate our clients through the regulatory process, including evaluations of global product acceleration pathways and opportunities for expedited development. Our vigilant oversight and updates ensure that your submissions not only remain in compliance but are strategically poised throughout the clinical trial process, fostering efficient progression, and minimizing regulatory hurdles.

When it’s time to transition from clinical trials to market, the Biologics License Application (BLA) and New Drug Application (NDA) in the US, as well as the Marketing Authorization Application (MAA) in the rest of the world, become the pivotal focus for launching a commercial product. Our team at Syner-G brings a wealth of experience to your BLA/NDA/MAA submissions, providing expert guidance through the intricate process of navigating varying global health authority (HA) requirements and focus. We facilitate and manage global HA meetings, ensuring your strategy is aligned with regulatory expectations across different regions. Moreover, we are adept at generating a core global dossier, essential for enabling lifecycle management of your product. From the preparation of your dossier and supply chain needs to addressing complex regulatory questions, we guide your application through every stage to ensure successful approval in all regions, leveraging our global insights and strategic foresight to optimize your market entry strategy.

Securing approval is just the beginning. Market success requires ongoing maintenance of your BLA/NDA/MAA and continued supply of commercial product. Our services extend to post-approval changes, annual reports, supplemental applications, and variations. Syner-G ensures that your product remains compliant with regulatory changes, adapts to new clinical data, and meets post-marketing commitments.