PRODUCT DEVELOPMENT SERVICES
Chemistry Manufacturing and Control
ICON Development Solutions provides leading-edge CMC services to help expedite the
sponsor's pharmaceutical development, applying scientific excellence and regulatory
expertise every step of the way. Our CMC team has vast experience in CMC planning,
management, implementation and regulatory strategy, applying knowledge from our
involvement in the biowaiver initiatives at the FDA, developing SUPAC-MR, SUPAR-IR
and IVIVC guidances.
Working actively with clients on formulations and manufacturing controls/specifications
for both new chemical entities and new formulations of approved products, our
expertise includes:
Providing the scientific & regulatory strategy for the CMC plan from Proof
of Concept through to commercialization
Applying SUPAC & biowaiver principals throughout all phases of development
Managing the CMC process, including Technology Transfer
Reviewing, compiling or writing all information & reports for the CMC section
of regulatory submissions
Utilizing the latest regulatory approaches & techniques for design,
development & approval of controlled release oral & parenteral dosage
forms
Determining optimal formulations
Evaluating innovative drug delivery systems & drug candidates for delivery
systems
