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

Gene Therapy Regulation by the FDA

Gene Therapy Regulation by the FDA

In the USA, gene therapy products are regulated as biological products by the FDA’s Center for Biologics Evaluation and Research (CBER). CBER regulates these products (cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy) for human use as per the applicable federal laws, including the Public Health Services Act (PHSA) and the Federal Food, Drug and Cosmetic Act (FD&C Act). This would include ‘cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoetic stem cells and adult and embryonic stem cells.’
The FDA’s Accelerating Rare Disease Cures Program

The FDA’s Accelerating Rare Disease Cures Program

In May of 2022, the Center for Drug Evaluation and Research (CDER) at the Food and Drug administration (FDA) launched the Accelerating Rare Disease Cures (ARC) program. This program sought to bridge the complexities of rare disease drug development with the pressing needs of patients. With this program’s initiation, the Rare Diseases Team was formed within CDER to work and maintain collaborative relationships between internal and external rare disease stakeholders and scientific experts.
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.

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