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.
Preclinical Studies
From identifying appropriate models to ensuring your study follows good laboratory practices (GLP), EMMA International supports all phases of pre-clinical studies.
Regulatory Strategy
Meet submission milestones and develop plans to mitigate challenges with a thorough regulatory strategy.
Pre-IND
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.
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.
Regulatory Submissions
Trust EMMA International to prepare INDs, BLAs, and other regulatory documents accurately and on time.
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.
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.
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
