Focus


While we have an excellent track record of success, there is no resting on our laurels when it comes to a client's project.  We drill down to the essentials and build a plan from there. 

Collaboration


TLI Development has a deep bench of independent consultants who can quickly adapt to any team organization, coming in and out of the program as their talents are needed. 

Mission

TLI Development is a pharmaceutical support services company that provides global state-of-the-art consultation for drug, biotechnology, and medical device development programs.  The three centers of excellence are regulatory, quality assurance (QA), and medical writing.

Our mission is delivering solutions to the challenges of today's fast-paced needs.  

Overview of our expertise

TLI Development provides a wide range of services with expertise in ...

  • Regulatory Dossier Preparation
    Over 30 years experience in compiling and filing regulatory dossiers for indications in oncology, cardiology, hematology, endocrinology, and immunology
  • Quality Assurance (QA) Support
    Assessing compliance of facilities (cGMP audits & PAI preparation), SOP review & revision, training, batch records review, and more
  • Biosimilars & Comparability Assessment
    Optimize comparability studies for biologics & biosimilars programs through Quality-by-Design (QbD), and Process Analytical Technology (PAT) for impact on structure-activity relationships (SAR) of critical quality parameters
  • Product Development
    Craft regulatory strategy and supporting documentation for pre-IND meetings, End-of-Phase II (EOPII) meetings, pre-NDA/BLA meetings, as well as development plans and project management
  • Medical & Technical Writing
    Author and review clinical protocols & clinical  study reports, CMC development reports, stability analyses, annual product reviews, and more
  • US Agent & Electronic Submissions Gateway (ESG)
    Provide support as a US Agent, support electronic submissions via the Electronic Submissions Gateway, write and file establishment registrations, drug product listings, facility self-identification, and more