Bioanalytical Consulting
BioData Solutions specializes in providing bioanalytical consultant services to developers and manufacturers of pharmaceuticals.
In today’s drug development environment, bioanalytical and stability challenges can make or break a drug platform. In-depth knowledge across a variety of technologies and methods, together with regulatory acceptance criteria are critical for success. Trust the know-how and guidance of experienced bioanalytical consultants to help navigate pharmaceutical development and the rapidly expanding world of traditional small molecule drugs and therapeutic proteins spanning monoclonal antibodies, biosimilars and antibody- drug conjugates.
Bioanalysis matters more than ever. We act as your guide and partner, helping organizations of all sizes select a drug development path, build product development strategy, and stay compliant with ever-increasing regulatory complexity and scrutiny.
BioData Solutions offers expertise and hands-on guidance in three disciplines:
Small Molecule
Large Molecule
Biosimilars
I have worked with BioData Solutions in support of one of my clients. Stephanie has been a great help and has really partnered with our client and myself. While reviewing results we had noticed some issues in the bioanalytical areas for a particular program that I was providing Toxicology support. We asked Stephanie to look into some of the inconsistencies that were noted. She was able to quickly define the specific issues, interface with the lab, the client and myself to provide guidance on how to work to resolve the concerns. Stephanie demonstrated her technical background, her ability to communicated the issues in a way that were understandable to non-specialist in the area and was very professional in her approach. I would recommend Stephanie and hope I get to work with her again on future projects.
Neal Sharpe, Ph.D.,
Principal at NA Sharpe Pharma LLC
BioData Solutions have been a pleasure to work with. The broad expertise in bioanalytical PK/immunogenicity assay development has been instrumental to the execution of our bioanalytical assay development endeavors to support our clinical development programs. Stephanie maintains a high degree of professionalism and efficiency in her work while being fully vested in our projects. She continues to be a valuable resource to our organization.
– Biotechnology company developing
therapeutics in oncology
Stephanie has been an invaluable resource to us as a consultant in helping with the development and oversight of bioanalytical assays. As a small company, we do not have an in-house bioanalytical expert to oversee and manage our bioanalytical activities at a CRO. Her background in assay development and validation as well as prior experience as a scientific leader at a CRO has been a great asset that has helped us develop and validate assays in a timely manner. She is very thorough and methodical in her approach and excellent at meeting timelines. Her performance as a consultant has exceeded all our expectations and look forward to using her as a consultant on all future programs at our company
Gurudatt Chandorkar, PhD
Director, Clinical Pharmacology
Akebia Therapeutics