AS Pharma Consulting, LLC

AS Pharma Consulting provides hands-on and strategic regulatory, clinical and nonclinical consulting support to pharmaceutical organizations from small biotech to large commercial-stage companies. Services include: • Regulatory strategy, submission planning for US INDs, Canada CTAs, EU and UK CTAs, IMPDs • Regulatory writing of IND and NDA documents (Modules 1 - 5), orphan requests, fast-track, breakthrough therapy designations, INN, USAN, annual reports, DSURs, health authority meeting requests and briefing documents • Project management, tracking and execution of regulatory submissions and clinical development activities • Medical writing and review of clinical trial protocols (first-in-human, Phase 2, pivotal, Phase 3 trials), investigator brochure, IND summary and overview documents, meeting requests, briefing documents and responses to health authority inquiries. • Clinical protocol development, preparation, review and execution • Due diligence for in-license and out-licensing of preclinical and clinical assets • Regulatory intelligence and development of target product profiles • Lead and prepare teams for health authority meetings and interactions with FDA, EMA, MHRA, PMDA • Regulatory leader for project teams and coach/mentor/groom regulatory managers to assume lead role • Nonclinical, toxicology, DMPK and clinical pharmacology data review, interpretation and problem solving • Author, review and provide strategic input for clinical and nonclinical regulatory documents • Develop Standard Operating Procedures (SOPs) to support drug development and regulatory best practices and toolkits to ensure quality and consistency throughout a growing organization • Partner with regulatory publisher to ensure complete and compliant health authority submissions