T&T is registered with FDA, reference FDA registration # 3015266446. T&T’s quality systems, SOPs, policies, and infrastructure are aligned with FDA, EMA, and JP regulatory requirements in order to develop and manufacture drug product to support Pre-Clinical and Clinical trials. All potential clients are invited to come tour our facility and conduct a contract-enabling audit. It is highly recommended to do so. It allows both teams to start to build a rapport and better understand our operations. However, given the pandemic and other time constrictions, we realize this is not always possible. Last year, we accommodated several virtual audits by conducting virtual tours, Zoom interviews, and document reviews. The last onsite audit was a one-and-a-half- day audit conducted on 01-Mar-21 by an overseas client who entered into a Pre-Clinical/Phase 1 development and manufacturing contract with us afterwards. The audit reviewed the entire quality system, as well as aseptic fill/finish processes. The first Clinical batch is scheduled to be filled in September 2021.
With a strong Quality presence on the manufacturing floor, we have been able to successfully provide material for IND filings in both US and EU markets.