Welcome
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Our Mission
We also provide training, standard operating procedures (SOP) writing, project management of technology transfers, comparability protocols, stability reports, development plans, as well as QA audits for current Good Manufacturing Practices (cGMPs) and controlled substances.
As part of an international consortium of consultants, TLI Development can rapidly assemble expert teams custom matched to your development needs, whether it's writing and training on a revised environmental monitoring program or navigating import/export regulations for India. For a summary of previous work experience, see Services.
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Drug development is a long, complicated, and expensive process. Despite the wealth of guidance documents and industry precedent, there is still often a great deal of judgment. A fast-paced program combined with a steep learning curve can spell disaster without an experienced team. Thus, the goal of this site it to make available some essential planning and project management tools gleaned from years of product development successes and mistakes.
Too often in this business, we don't hear the words, "I don't know" and pay a dear price. This firm is dedicated to finding experts in every field and, in our own humble way, heeding the limits of our own expertise.
Key HighlightsThis site is broken into major areas: templates, articles & presentations, biosimilars, and controlled substances. A description of each subsection is provided below.
The simple purpose behind making these readily available is that they enable a team to immediately start organizing and assessing each major section of the submission or audit. Secondly, they may prompt awareness of an area that might have been overlooked by the team - an area that could have great import for product quality.
We hope the combined information will enable you to do your job more efficiently, but most importantly, to enhance awareness and avoid a miscalculation - one with significant impact on the safety and efficacy of the product, all of which will impact the timing, cost, and success of your project.
Templates CentralThis section of the website contains numerous document templates for project management, product development, IND, NDA, CTD, & BLA planning, tables of contents, audit checklists, and more. The idea is to make your job more efficient so that you can focus on the issues. Some of the documents you'll find described there include:
Articles & PresentationsBiologics Development
This section of the website contains copies of presentations for biotech development, which include:
Biosimilars, Follow-on Biologics, and Therapeutically Equivalent BiologicsThis section of the website contains copies of presentations, articles, legislative summaries, links to other sites, and much more. Some key documents include:
Controlled Substances ComplianceThis section of the website contains presentations regarding controlled substances compliance, audit checklists, and more. Note that these presentations are from a seminar course last taught in 2001 so some of the regulatory aspects have changed, such corporate recordkeeping and legislative overview. Some key documents include:
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TLI Development is a
pharmaceutical consulting firm that provides cost-effective support in
regulatory affairs, medical & technical
writing,
and quality assurance (QA) areas for a wide range of both drug and biotechnology development
programs.
