Contact Us

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

Contact Us

At Syner-G, our tailored services are designed to navigate the complexities of drug development and regulatory submissions, ensuring your products reach the market with precision and efficiency. This includes regulatory Chemistry, Manufacturing, and Controls (CMC) document preparation, technical writing, clinical regulatory medical writing, and electronic publishing services.

Here's a deeper look at how we tackle the
challenges and opportunities in Drugdevelopment:

IND/CTA Strategy, Submissions and Management – Your Gateway to Clinical Development Strategic IND/CTA Planning

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.

Ongoing IND/CTA Management

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.

BLA/NDA/MAA Strategy, Submissions and Management – Pathway to Market Approval Requires Robust BLA/NDA Submission Strategy

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.

Comprehensive Post-Market Maintenance

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.

Syner-G’s Full-Cycle Regulatory Expertise

Our approach to submissions and maintenance is comprehensive. We begin with an in-depth analysis of your data, followed by the development of a long-term strategic regulatory plan. This plan is then executed through:

Regulatory Intelligence
Our team stays ahead of evolving regulations and guidelines, integrating this knowledge into your submission strategy.
Scientific Rigor
We ensure that your data are presented with the scientific rigor that regulatory agencies demand.
Gap assessments and risk mitigation plans
Our team can execute a detailed gap assessment at any point in clinical development, working with your SMEs to develop appropriate risk mitigation plans and an appropriate regulatory roadmap to registration.
Regulatory Roadmaps
Leveraging the gap assessment and risk mitigation plans combined with accelerated regulatory pathway options, our team will develop a regulatory roadmap specific to your product, enabling quick to market approaches.
Stakeholder Collaboration
We coordinate with all stakeholders, including clinical, manufacturing, and marketing teams, to ensure that the submission reflects all facets of product development.
Expert Document Preparation
Our technical writers are experienced in creating clear, comprehensive, and compliant documentation for regulatory submissions.
Quality Control Processes
Before submission, every document undergoes rigorous quality control to ensure compliance with regulatory standards.
E-Submission Expertise
We are adept in electronic submission processes and will ensure that your submission meets the technical requirements of regulatory authorities, facilitating a smooth review process.

Syner-G is more than a service provider

We are a partner invested in the success of your product. Our team combines strategic vision with operational excellence to guide your product through regulatory milestones with confidence and precision. From the intricacies of initial IND/CTA submissions to the complexities of maintaining BLA/NDA/MAA post-approval, Syner-G stands by you, ensuring your regulatory strategy is executed flawlessly.

Partner with us and experience the Syner-G difference, where innovative strategies meet seamless execution.