Regulatory Solutions

NDA, BLA, and MAA Submissions

Regulatory strategy
Meeting Requests and Briefing Documents
Nonclinical Pharmacology, Pharmacokinetics, and Toxicology Summaries (Modules 2.4, and 2.6.1-2.6.7)
Chemistry, Manufacturing, and Controls Summaries (Modules 2.3 and 3)

Drug Development Strategies

New molecular entities and biologics, including monoclonal antibodies and therapeutic proteins
Submissions to multiple agencies
Special programs, including orphan drug applications, fast track, breakthrough therapy, and rolling review

Therapeutic Areas

Metabolism
Immunology
Oncology
Pulmonary
Renal Disease
... and more