At ThenSoar CMC Consultant, we have over 12 years of experience focused on the pharmaceutical development of nucleic acid-based drug substances and polymeric nanocomplex drug products.

We have global experience in the development, qualification and validation of complete methods and validation expertise in a wide range of analytical methodologies, including bioanalytical methods using PK/ADME samples, chromatographic and electrophoretic analysis, ELISA and nanoparticle characterization.

Our scientific approaches are useful to thoroughly investigate possible causes of Out of Specification or Out of Trend in release and stability testing to understand why a problem has occurred so that it can be prevented in the future. We work closely with analytical and manufacturing laboratories to coordinate investigation strategies, to generate data-backed and QC-approvable reports and corrective/preventive actions (CAPAs).

We have proven experience in nucleic acid base API chemical manufacturing processes and subsequent formulation and generation of nanoparticles to achieve the desired shelf life of the drug product in liquid form.

Over the years, we have generated a strong track record of managing suppliers (CROs and CMOs) who are proficient in technical-related activities.

 At ThenSoar CMC Consulting, we have successful experience in the first-time approval for human use of new chemical entities, as well as in handling Regulatory Agency inquiries and making response letters that allow rapid clearance through IND and IMPD to commence clinical studies.

Our commitment is to continually expand our knowledge to provide you with the best service. Contact us and find out how we can help you.