PHARMACEUTICALS

 Our consultants have extensive knowledge and real-world experience in the development and implementation of regulatory strategies for drug substances. We have experience writing and publishing eCTD submissions and can assist with phase appropriate guidance from clinical through commercial phase products in support of IND/IMPD/NDA/ANDA applications. Our in-depth understanding of the ICH/FDA/EMA guidelines combined with PhDs in Organic Chemistry, allows us to develop a scientifically sound impurity control strategy, set phase-appropriate specifications, and justify regulatory starting materials. We have a successful history of responding to health authorities worldwide including requests for information and major regulatory deficiencies.

Our consultants have years of experience in establishing control strategies for impurities in drug substances, including potential genotoxic impurities and nitrosamines. Due to the challenges and costs with establishing analytical methods and manufacturing controls for highly toxic impurities, it is critical to identify these impurities early in product development with the goal of avoiding their formation by modification of the synthetic route or mitigation of risk by developing a control strategy that is accepted by regulatory authorities. 

Our PhD scientists have over 20 years’ experience in process research and optimization of synthetic routes for APIs. We offer a deep expertise in improving and optimizing process routes and establishing process- and synthesis-criticality. To be successful and efficient at new process development, it is essential to have a CMC mindset and ensure that analytical method development, stability studies, forced degradation, and solid-state characterization are conducted in parallel with synthetic process development.