Scientific, Regulatory & Quality
Medical Writing
Accelerate with clear, compliant clinical documents.
Syner-G recognizes the critical role of high-quality, regulatory-compliant medical writing for advancement of clinical programs. Our experienced writers turn complex data into precise, submission-quality documentation—helping you meet global standards, avoid agency back-and-forth, and move forward with confidence.
Challenges we can help solve:
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/BLAs, MAAs, and agency briefings—without compromising quality.
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.
Data errors, data inaccuracies, inconsistent terminology, or inconsistent formatting
Our cross-functional experts identify and remediate documentation gaps, harmonize submission standards, and support audit readiness—ensuring your programs meet evolving regulatory expectations even post-launch.
Client Return Rate
Assets Supported
INDs Filed
NDAs / BLAs Filed
Expertise in every document.
Our Approach
Specialized, scientific writing — meeting global requirements.
Our medical writers integrate seamlessly into your product teams. From authoring to quality control, formatting, and coordination, we help clients meet tight timelines—without compromising on quality.
- Scientists: well-versed writers who craft clean and precise documents that meet global regulations
- Quality Control: data integrity assessments and consistency in style and messaging
- Fit-for-Purpose, Risk-Based Approach: grounded in science, regulatory, and operations
- Hands-on Support: for all phases—from First-in-Human studies through commercialization
We can help with:
Crafting NDAs / BLAs
Clinical Study Reports and Protocols
Safety Narratives
Investigator Brochures
IND / IMPD / CTA Applications and Amendments
Annual Reports to Regulatory Agencies
Briefing Documents for Agency and Advisory Committee Meetings
Complex Data Analyses and Concise Presentation of Study Results
A complete, fully-integrated solution.
Discovery Sciences
CMC Strategy & Development
Regulatory Strategy
Quality & Compliance
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Let's move from science to success.
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