About Us
Stephen A. Wald, Principal
Consultant with broad operations background in pharmaceutical R&D (API and dosage form), technical operations, supply chain and alliance management, largely utilizing a “virtual”/out-sourcing model. Creative problem solver with broad scientific background and strong appreciation for business needs and risk management, experienced at balancing internal resources and external vendors. Diligence lead, responsible for all aspects of chemistry and formulation R&D, and commercial supply chains, for both licensing and acquisition. Experienced at preparing drug candidates for licensing. Strong operational experience with a successful track record of consistently reaching operational, financial, and strategic targets to ensure business success (e.g., led development and preparation of five NDAs, and oversaw four product launches). Negotiated numerous CMC contracts, including supply, quality and R&D master service agreements. Strong appreciation for intellectual property and its value to drug development and commercialization, along with diverse experience with a range of corporate cultures. Built and maintained effective, collaborative relationships with internal customers (e.g.. R&D, Sales, Marketing, Business Development, Legal, Finance) and external collaborators (e.g., FDA, CROs, CMOs, alliance partners) .
