Solutions

Scientific, Regulatory & Quality

Expert guidance from discovery to approval—and beyond.

The expertise to move your program forward.

At Syner-G, we help biopharma companies navigate the high-stakes journey from early development through post-approval with clarity, speed, and scientific rigor.

As a strategic development and delivery partner, we bring deep expertise across discovery, CMC, regulatory, medical writing, and quality systems—guiding your program from preclinical stages to global submissions and lifecycle management.

Our integrated approach reduces risk, aligns teams, and ensures that every step you take moves you closer to approval and market impact.

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.
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.
Limited internal expertise to guide early decisions
Our integrated teams guide your earliest decisions with cross-functional expertise that aligns science, quality, and long-term objectives.
Lack of a coherent, forward-looking development plan
We design and execute forward-looking, risk-managed programs that reduce downstream issues—and speed your asset through development and approval.

0%+

Client Return Rate

Assets Supported

INDs Filed

NDAs / BLAs Filed

Need clarity at a critical point in your development?

Let’s talk through your program goals and how we can advance them.

Talk to an Expert

Your trusted scientific, regulatory, and quality partner.

We’re more than service providers—we’re scientific and regulatory allies who help clients make better decisions, avoid costly setbacks, and reach approval with confidence.

Why Choose Syner-G

Integrated, end-to-end support.

Our model integrates discovery, development, and regulatory execution into one continuous flow—minimizing handoffs, avoiding rework, and accelerating progress.

Deep scientific and regulatory expertise.

Our teams include scientists, regulatory leads, quality experts, and medical writers—many with PhDs, PharmDs, and decades of hands-on experience guiding assets through development and approval.

Strategic foresight meets practical delivery.

We combine strategic insight with executional strength. From CMC planning to submission support, we help you anticipate what’s ahead and act decisively at every stage.

The right support at the right time.

Whether you need full-scale support or targeted expertise, our delivery model flexes to your timeline, structure and needs.

Built-in quality and regulatory alignment.

Our frameworks embed regulatory and quality strategy into the development process helping you avoid delays, reduce risk, and stay audit-ready across geographies.

A track record you can trust.

We've supported hundreds of global biopharma companies across a variety of therapeutic areas and modalities, advancing complex therapies to approval and helping clients scale with confidence.

Key Focus Areas

Discovery Sciences

Helping you design studies, essays, and data packages that will withstand future scrutiny and position your assets for downstream success.

Learn More

CMC Strategy & Development

An integrated approach that ensures phase-appropriate control strategies and sets your asset on the most efficient course toward approval.

Learn More

Regulatory Strategy

From IND and CTA submissions through pivotal trials, approval, and beyond—we help you avoid rework and keep momentum throughout your program’s lifecycle.

Learn More

Medical Writing

Every protocol, clinical study report, and submission module is crafted with regulatory reviewers in mind—communicating complex data with precision, consistency, and credibility.