Regulatory and Quality

In the Life Sciences, regulatory and quality assurance functions are often viewed as critical conduits to the regulator agencies. Whether it’s maintaining compliance, or strategizing endpoints, these functions are instrumental to the success of any company.

We’ve helped provide solutions for clients with strategic regulatory challenges in preclinical, clinical, CMC, operations, and advertising/promotion. Challenges such as preparing for Pre-IND/MAA, End of Phase II, or pre-NDA/BLA meetings, responding to product questions from the agency, and determining endpoints with small or large patient populations. Our search results have led to the successful design and implementation of multiple clinical trial programs that align with immediate and long-term global development goals of our clients, protocol design, preparation, submission, and successful outcomes of clinical trial applications. 

When our clients think about quality, they want to mitigate all risks that could lead to a warning letter, untitled letter, 483, recall, or even a consent decree. Many of our clients simply have a Quality System that needs updating, a Pre-Approval Inspection fast arriving, or inefficiencies with their batches. Our searches have also helped clients pass inspections with zero observations, implement robust global GxP quality systems, and improve efficiency by streamlining document flow.

At Prestige Scientific, we understand strategic challenges and have helped clients overcome them while adhering to timelines, staying under budget, and eliminating risk in the process.