As Pharma Consulting,

AS Pharma Consulting provides hands-on and strategic regulatory and pharmaceutical development consulting support to multiple pharmaceutical companies, ranging from small startup to large commercial-stage organizations. Services include: • Plan, author and review documents for regulatory filings such as INDs, CTAs, annual reports (DSUR), IBs, meeting requests, briefing documents and responses to health authority inquiries • Expertise on strategy, timing and execution of clinical development plans pertaining to regulatory affairs, submission planning, clinical trials, intelligence and development of target product profiles • Clinical protocol development, authoring and review • Lead/participate in, and prepare teams in activities pertaining to health authority interactions • Regulatory project lead on project teams and mentor regulatory staff • Develop SOPs, best practices and toolkits to ensure quality and consistency throughout organization, including coaching manuals for regulatory liaisons on discovery and/or development teams • Design, review and interpret data for preclinical DMPK, Tox and Clinical Pharmacology studies • Bring Regulatory Operations in-house; evaluate and implement submission/publishing tools