Process Research
Services of Suven Pharma involves the development and optimization of chemical process used in manufacturing drug substances and intermediates.
Our R&D team of over 400+ scientists has extensive experience in formulation research and analysis working with global partners for their formulation development and analytical support. Our collaborative practice executing over 880+ projects and experience of over 33+ years, helps in accelerate the testing of molecules through the early stages and achieving commercial goal faster.
The process research services offered by Suven Pharma ensures the
Efficient, safe, and cost-effective production of drug substances and intermediates includes the following:
Route Scouting:
Identify the most efficient and cost-effective synthetic routes for producing drug substances and intermediates.
Process Development:
Develop and optimize chemical processes to improve yields, improve quality, cut cycle times, reduce costs, and minimize waste generation.
Process Scale-Up:
Process characterization and scale up from laboratory to pilot and commercial scales, ensuring that the process is reproducible and meets the required quality standards.
Process Safety Evaluation:
Process safety evaluations are conducted as part of scale up activities to identify and mitigate potential hazards associated with chemical processes.
Analytical Method Development:
Develop and validate analytical methods to measure the quality attributes of drug substances and intermediates.
Regulatory Support:
Provide regulatory support and guidance for filings and compliance with the regulatory requirements of various regulatory agencies, such as the USFDA, EMA and others.