QARA Services offers a unique combination of depth and breadth of regulatory, quality and compliance services to the biopharmaceutical industry, including:
Regulatory Strategy and tactics for FDA and international health authorities, Submission development, review, filing response to FDA requests; Quality Programs: GMP, GLP, GCP Assessment, audits, processes Training, Due Diligence, Interim Leadership and Pharmacovigilance.
Product Technologies - Drugs: Small molecules, Oligos (phosphorodiamidate morpholino oligos, phosphorothioates). Biologics: (rDNA, MAb, peptides, vaccines, gene therapy, cell expansion/transplantation).
Therapeutic areas - Oncology, Viral Diseases, Genetic Rare Diseases, TNF-mediated diseases, Cardiology, Hematology, and Antibiotics. |