Having worked with over one thousand active pharmaceutical ingredients and hundreds of drug products, Aptuit have developed a comprehensive understanding of how to maximize development success. Whether you need an in-house short course on chemical development, expert advice for claim construction, intellectual property management, or proving or disproving patent infringement, our expert consulting group can help.
Our solid state chemistry experts can assist you along the many avenues of the drug development process. If you need assistance to prepare for an end-of-Phase-II CMC meeting with the FDA, our experts can work through your data and give you a detailed plan of requirements and recommendations to ensure a smooth meeting. We can also attend the meeting with you, to be there for hands-on consulting. We can also provide all the required data and documentation for an IND filing. Our experts can provide further assistance through all stages of patent prosecution and patent litigation (USA and overseas), serving in the role of an expert witness or consultant.