Mandy Fitzl's Contact Details

Mandy Fitzl's Company Details

We deliver CDMO / CRO services, from 8 sites, working alongside Pharma & Biopharma innovators to advance new therapies to market. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody drug conjugates) and gene therapies (such as RNA and DNA oligos). Our drug development services advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our GMP clinical supplies manufacturing capabilities include sterile injectables, ophthalmics, capsules, tablets, solutions/suspensions, and topicals.Our commercialization and manufacturing support comes from our FDA-registered laboratories that provide submission-ready methods validation reports, finished product release testing, ICH Stability programs, raw materials clearance programs, extractable-leachable studies, and full microbiology laboratory support.