The global scenario today demands the best collaborative practices between different parts of an organisation thereby maximising the output. One of the key performance indicators in Pharma R&D is the number of new drug candidates in pipeline. Nominating candidates with best possible properties gives a higher likelihood for it to survive and convert to the required NCE.
A pronounced need to make critical judgements and forecasts on cost of goods for NCEs/APIs, scalability, route scouting and design, intellectual property, etc. is more norm than a requirement. At GVK BIO, we strongly believe in the importance of effective QbD during development of late stage NCEs. We involve cross-functional team of process chemists, analysts, process engineers, quality assurance, sourcing and manufacturing, which helps us to consider the right input variables during designing and developing the process. Cumulative wisdom of the team during FEMA ensures robust processes resulting in improved efficiency, reduced risk and fewer failures. This teamwork also enables us to achieve one of the elements of ICH Q 10, continuouss improvement, within the boundaries of design space with minimum regulatory concerns for the customer.
GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customisation as per client’s need so as to perform and progress in a collaborative partnership.
Our scientists are experienced in developing short and efficient process for complex pharmaceutical products by utilising in-house expertise and state-of-the-art technology.