The J. Molner Company, HQ in Tallinn, Estonia is a comprehensive generic CDRO with experience in topical, liquid, and sterile dosage forms. Our team is dedicated to providing you with services that help you develop faster, deepen internal capacities, and achieve your targets. With a highly educated team of experienced scientists, we have the capabilities to help you tackle some of the toughest challenges. Our core service offerings are centered around IVRT for semi-solid bioequivalence, Post Approval Change Management of existing or shelved applications, analytical chemistry, and drug development. We are EU-GMP release capable and have an MRA with the FDA. IVRT We specialize in IVRT testing, providing comprehensive support from development to post-approval changes for semisolid dosage forms throughout the product lifecycle. POST APPROVAL CHANGE MANAGEMENT We present a unique harmonization between our technical laboratory capabilities and specialized regulatory expertise to manage ANDA changes through the FDA, on your behalf. ANALYTICAL SERVICES Using our newly built laboratories, we provide a wide range of analytical services to help support your team in compliance with cGMP and ICH guidelines.
