pHARMACEUTICAL TECH TRANSFER & DEVELOPMENT

Pharmaceutical Tech Transfer & Developments

Technical transfer to T&T Scientific Contract Development and Manufacturing Organization (CDMO) assembles the efforts of formulation and manufacturing departments teams from the start of preclinical or clinical batches through commercialization activities and throughout the life cycle of a product. During the selection process, we work closely with clients on critical areas that will need CDMO in preparation for the Statement of Work (SOW). This process can be during preclinical, phase I, phase II, and phase III clinical trials. The tech transfer process includes receiving all developed information from clients' research and lab results, risk assessment, manufacturing process development, analytical methods, and capturing information in development reports that prepare for regulatory and Investigational New Drug (IND) Application submission.

At our team in T&T Scientific, it is essential that a technology transfer team include cross-functional subject matter experts in the fundamental science of nanoparticles, analytics, technology, regulatory, manufacturing, and compliance in different departments of our company. T&T set up weekly meetings with clients' representatives to provide updates on all previous week's activities, improvements, challenges, ideas, and paths forward for short and long terms.

Information Transfer Under NDA

The non-Disclosure Agreement (NDA) is referred to as a Confidential Disclosure Agreement. These agreements govern the terms for exchanging confidential information between T&T Scientific and an outside party and are negotiated, drafted, and signed by both parties to protect confidential information exchanges. The next step is the technical information exchanges and discussions between the two parties to start drafting and iterating the proposals. You can download the Standard Mutual Non-disclosure Agreement of T&T Scientific here

Formulation Development and Optimization

Analytical Methods Development

Manufacturing Process Development

Comprehensive and Standard Reports for IND Submission

Quality Assurance and Quality Controls

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