Scientific, Regulatory & Quality
Regulatory Strategy
Navigate the regulatory path with clarity and confidence.
A well-built and well-executed regulatory strategy is essential for development and approval. In fact, it could mean the difference between market success and costly delays.
Syner-G streamlines your path-to-market by leveraging our extensive support in global regulatory strategy and submissions. We design and execute regulatory strategies that avoid mistakes, reduce delays, and prepare your team for every interaction with global health authorities—ensuring a smooth transition from discovery to post-commercialization.
Our end-to-end approach is a powerful catalyst for companies—it enables them to navigate complex regulatory requirements while accelerating the delivery of breakthrough therapies to patients.
Challenges we can help solve:
Regulatory uncertainty and evolving expectations
We help you interpret and apply global regulatory requirements through a fit-for-purpose, risk-based approach grounded in scientific and operational insight. Whether you’re pursuing an IND, NDA, BLA, or global filings, our experts guide you through every step with clarity and precision.
Complex, time-sensitive submission demands
Our experienced scientists craft clear, compliant regulatory documents that meet global standards and support every step of the submission process. From authoring and editing to formatting, QC, and coordination, we help clients meet tight timelines for INDs, NDAs, MAAs, and agency briefings—without compromising quality.
Increased complexity in global lifecycle management
We provide strategic and operational support for global variations, line extensions, and post-approval changes—helping clients maintain product quality, meet evolving regulatory expectations, and keep therapies accessible to patients worldwide.
Growing volume and complexity of regulatory submissions
Our teams support authoring, QC, formatting, and coordination for large-scale regulatory submissions, from routine updates to major global filings—ensuring consistency, efficiency, and regulatory compliance across functions and geographies.
Client Return Rate
Assets Supported
INDs Filed
NDAs / BLAs Filed
Ensure a smooth journey from laboratory to market.
Our Approach
Seamless regulatory support — across phases, functions, and geographies.
Our team understands the complexities of development from both a scientific and regulatory perspective. This approach ensures that your non-clinical and clinical strategies are expertly developed with a clear understanding of international requirements.
- Regulatory: aligned with FDA, EMA, and global regulations
- Audits & Assessments: gap assessments, risk registers, and risk mitigation
- Roadmaps & Custom Support: to speed up timelines—by months or even years
We can help with:
Global Regulatory Strategy— North America, EU, APAC, LATAM, RoW
A complete, fully-integrated solution.
Discovery Sciences
CMC Strategy & Development
Medical Writing
Quality & Compliance
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Let's move from science to success.
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