Investigational New Drug Approval of Potential COVID-19 Medication by FDA

EuTech Scientific Services, Inc.’s (EuTech) experienced team has worked hand-in-hand with IHP Therapeutics (IHP) to perform a complete characterization of their biological drug IHP-009 to ensure that it meets FDA regulations.

The characterization data submitted to the FDA resulted in IND approval of IHP-009 in March of 2021.

Characterization of biologics is different than small molecules that has a well-defined structure. Biologics are very large in size, and their structure identifications have to include inherent variability associated with being of biological origin.

“Our team is honored to be a trusted lab of choice to perform complete characterization of a biological drug in a timely manner to ensure sensitive worldwide Covid-19 cure development progress,” said Dr. Raghvendra Sahai, President, ARL-EuTech Scientific Services, Inc.

About ARL-EuTech Scientific Services

Founded in 1994, EuTech partners with Pharmaceutical and Medical device companies in their Drug Development and quality assurance programs strictly adhering to FDA’s GLP/GMP guidelines. It is also DEA licensed Schedule (I-V), and extends services to dietary supplements, nutraceuticals and raw material suppliers. It has helped several pharma companies in detailed analysis of raw materials, API, excipients becoming their formulation development partner.

Pharmaceutical companies for the last two decades have utilized EuTech to ensure that their packaging is safe, and all the extractable leachable data meets FDA guidelines, further performing all the required testing for each lot release. In June 2021, EuTech became a member of the Tentamus family of companies, joining hands with ARL to become ARL-EuTech, offering its pharmaceutical clients better and more comprehensive services.