This study addresses the product-launch planning problem in the chemical-pharmaceutical industry under technical and market uncertainties, and considering resource limitations associated to the need of processing in the same plant products under development and products in commercialization. A novel approach is developed by combining a mixed integer linear programming (MILP) model and a Monte Carlo simulation (MCS) procedure, to deal with the integrated process design and production planning decisions during the New Product Development (NPD) phase. The Monte Carlo simulation framework was designed as a two-step sampling procedure based on Bernoulli and Normal distributions. Results show the unquestionable influence of the uncertainty parameters on the decision variables and objective function, thus highlighting the inherent risks associated to the deterministic models. Process designs and scale-ups that maximize expected profit were determined, providing a valuable knowledge frame to support the long-term decision-making process, and enabling earlier and better decisions during NPD. (C) 2017 Elsevier Ltd. All rights reserved.