Chemically synthesized drug substances and drug products, from first-in-human through post-approval. Regulatory CMC support across API and drug product development, analytical method validation, process characterization, and control strategy, for NDA, 505(b)(2), and ANDA pathways alike.

Antisense, siRNA, and synthetic peptide therapeutics are modalities where CMC complexity often outpaces precedent. Support across solid-phase synthesis and purification development, impurity characterization, and control strategy, in a regulatory landscape with fewer regulatory precedents than small molecules or biologics.

Recombinant proteins, monoclonal and bispecific antibodies, antibody-drug conjugates, vaccines, and stem cell therapies. Support across cell line and cell bank development, upstream and downstream processing, analytical characterization, potency assay strategy, and control strategy, through BLA/MAA, comparability, and post-approval change. For ADCs, that includes linker-payload and conjugation CMC, where small molecule and biologics expectations meet.