Overview

AS Pharma Consulting supports multiple pharmaceutical companies, ranging from small startup to larger commercial-stage organizations. Services provided include, but are not limited to: • 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 • Developing best practices and toolkits to ensure quality and consistency throughout organization, including coaching manuals for regulatory liaisons on discovery and/or development teams • Preparing and reviewing documents for regulatory filings such as INDs, CTAs, annual reports, meeting requests, briefing documents and responses to health authority inquiries • Lead/participate in, and prepare teams in activities pertaining to health authority interactions • Regulatory project lead on project teams and coach regulatory managers to assume lead role • Authoring, reviewing and providing input for clinical regulatory documents • Clinical protocol development, preparation and review • Reviewing data and providing guidance for preclinical DMPK, Tox and Clinical Pharmacology • Assisting in bringing Regulatory Operations in-house, evaluating and implementing submission/publishing tools