Other submissions teams work at arm’s length from the lab. Not ours. We embed our regulatory specialists within the R&D lifecycle from day one, ensuring that every decision made in your project’s earliest phases sets you up for streamlined FDA approval.
From blockbuster OSD forms to precisely formulated suppositories, our PhDs and analytical chemists know it all—and they have the end-to-end technology and quality manufacturing systems to turn that knowledge into your next high-quality commercial product.
Our U.S.-based facilities, which offer over 100,000 square feet of flexible manufacturing capacity, are engineered to deliver safety and compliance on an accelerated timeline. Our DEA-licensed locations also welcome projects that involve Class II-V controlled substances.
Our history of FDA approvals and successful product launches tells a story of rigorous quality-by-design.
No matter its complexity, we have the skills and technologies to manufacture your next oral therapeutic.
Trust your liquid or suspension project to the team that ships 10M cough & cold products each year.
We have the specialized skills and equipment to deliver creams, ointments, chewables, and more.
You don’t get to 35M doses a year without knowing precisely how to manufacture this niche drug form.
We support our clients’ scale-up, distribution, and reshoring from 3 fully equipped, US cGMP facilities.
From NDAs to 505(b)(2)s, our submissions team knows what regulators expect—and how to deliver it.
LGM PHARMA
Call Toll-Free: 1-800-881-8210
Corporate Headquarters:
6400 Congress Avenue, Suite 1400
Boca Raton, FL 33487, USA
