Explicat Pharma

Explicat Pharma is a private, service-oriented consultancy specializing in Chemistry, Manufacturing, and Controls (CMC) project management and pharmaceutical development. The company leverages a team of experienced pharmacists and engineers to offer a broad range of services, including formulation development, analytical method validation, regulatory strategy, and the implementation of Process Analytical Technology (PAT). Its business model is built on providing outsourced development expertise to client companies, helping them navigate complex technical and regulatory pathways to bring products to market. Explicat is revenue-generating, certified as a training center, and serves a diverse clientele across multiple regulated sectors.

Integrated service methodology specializing in Process Analytical Technology (PAT) and Quality by Design (QbD) for pharmaceutical and medical device development. Expertise includes real-time monitoring (e.g., wireless temperature measurement in lyophilization) and risk-based development approaches.

Explicat competes in a crowded field including large global CDMOs (e.g., Lonza, Catalent), specialized pharmaceutical consulting firms, and the internal development teams of potential clients. Its differentiation lies in its deep, hands-on expertise in PAT/QbD implementation, a focus on the German/European market, and its certified training center status.