SERVICES

At the J. Molner Company, our team is dedicated on providing you 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 generic drug development, analytical chemistry, and ongoing stability services.

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.

EU MARKET RELEASE

Our laboratory team in conjunction with our Qualified Person can help you get your product to the European Market in accordance with Annex 16 of EudraLex requirements.

DRUG DEVELOPMENT

We take your concepts and turn them into generic drug opportunities through a robust development process for the United States, Canada, and Europe.

STABILITY SERVICES

We have pioneered an economical ICH commercial drug stability service that gives you operational flexibility with Nordic quality.