Our goal is to help you move quickly and efficiently from preclinical into clinical development. During the development process, we will adhere to your trial schedule. By the time companies reach Phase II trials, they not only need GMP material with strong regulatory support and documentation for regulatory filings; they likely need to have decided on key issues surrounding the where and how of manufacturing of both the finished product and the API.
LGM Pharma has extensive knowledge and experience providing clients with suitable material that is accompanied by the proper regulatory certifications to meet most countries’ regulatory requirements.
Whether it is a generic, a novel delivery system, or a combinatorial product, we have supported hundreds of projects and have aggregated the mindshare and the experience that have been an invaluable resource to our clients. Because of the scale and scope of projects with which we are involved, we provide a seasoned perspective and wealth of valuable insight that our clients greatly value.