Gene and Cell Therapies

Bring your biologic therapies to market faster and more efficiently with sound development and regulatory strategies. EMMA International’s in-house scientific, regulatory, and quality experts work with your team from development through post-market, providing strategic direction and oversight.

Whether you’re developing a vaccine, cell therapy, or gene therapy, we provide the guidance, review, and strategy to set you up for success.

Biologics Timeline

Product Development

EMMA International plays a strategic role in product development from day one. Our in-house scientific experts and partner laboratories not only provide valuable input, but also work with you to meet your business needs while ensuring compliance. When you’re ready, we’ll be there for strategy and submission.

Learn more about product development.

Preclinical Studies

From identifying appropriate models to ensuring your study follows good laboratory practices (GLP), EMMA International supports all phases of pre-clinical studies.

Learn more about preclinical studies.

Regulatory Strategy

Meet submission milestones and develop plans to mitigate challenges with a thorough regulatory strategy.

Learn more about our regulatory consulting.


Get the most value from your Pre-IND meeting and shape your path to market. EMMA International will help formulate the questions for the FDA, prepare the briefing package, and help you prepare for this important step.

Learn more about pre-IND.

Clinical Investigations

Regulatory approvals depend on successful clinical trials. We help move your trial to the finish line with study design development support. We also identify and monitor clinical sites and generate clinical investigation reports, among other activities.

Learn more about clinical investigations.

Regulatory Submissions

Trust EMMA International to prepare INDs, BLAs, and other regulatory documents accurately and on time.

Learn more about regulatory submissions.

Quality Management System Development

Using EMMA International’s proprietary QMS methodology, CLIC™, we develop and implement QMS systems that are Compliant, Lean, Integrated, and Customizable.

Learn more about CLIC™ QMS Development.

Post-Market Surveillance

As you move into late-phase trials, turn your attention to commercialization and innovation. EMMA International will take care of post-market surveillance and vigilance reporting activities.

Learn more about post-market compliance.

Move your biologics forward with EMMA International. Speak with one of our experts to learn more.

Ready to learn more about working with us?

Gene and Cell Therapy Resources

The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
New Imaging Drug for Ovarian Cancer

New Imaging Drug for Ovarian Cancer

In November of 2021, the Food and Drug Administration (FDA) approved Cytalux. Cytalux is a new imaging drug intended to assist surgeons with the identification of ovarian cancer lesions1. This new drug was designed to assist in locating additional ovarian cancer tissues that can be...

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