Regulatory


Over 28 years Experience in regulatory strategy and dossier preparation
TLI Development provides development expertise and dossier preparation for a wide variety of drugs, biologics, and devices in the US and Europe. Having experience authoring over 100 INDs and more than a dozen market applications, we will assemble an expert team to deliver results customized for your program and your budget. 

TLI Development provides regulatory support for ongoing IND, NDA, and BLA applications, such as annual reports, stability updates, adverse event reporting (pre- and post-approval). For specifics, click below.

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Quality Assurance


Able to provide a full suite of quality assurance services
We provide a full range of QA support services, such as preparation for pre-approval inspection (PAI), supplier qualification facility audits, manufacturing document review and approval, training, SOPs, as well as setting up corrective action & preventive action (CAPA) databases, and more.  For details of our experience and how we may assist you, click below.
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Medical Writing


Technical writing support for regulatory filings and more
TLI Development has extensive experience in writing clinical documents (e.g., informed consents, protocols and study reports, integrated summaries of safety and efficacy (ISS & ISE)) and CMC documents (e.g., product development reports, annual product reviews (APR), stability summaries), and much more.  For a detailed listing, click on the link below.
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Global Support

Integrated Development from Tierra del fuego to Reykjavík

Whether you are filing an IND in the US, a CTA in Canada, or an authorization in Mexico (to the COFEPRIS), we will implement an integrated development plan that works within your budget.

With experts in Canada, the United Kingdom, Belgium, Germany, China, Taiwan, Japan, Mexico, Latin America, and India, TLI Development can provide international support of your programs at all stages of development. We deliver all the productivity you would expect from an international contract research organization - minus the bloat.

Due Diligence Reviews & Operations Consulting


Interested in a product development program but not quite sure if you're getting the whole story?  We can perform detailed reviews of programs for investors and due diligence audits.  

What we do best ...

With over 31 years of combined development and regulatory experience, TLI Development provides a broad range of support services quickly and efficiently.    

  • Product Development & Regulatory Strategy
    Strategic & technical support of nonclinical studies, CMC, and clinical design from the pre-IND stage to post-approval  
  • Technology Transfer
    Project and document management of manufacturing process transfers or analytical methods for optimized results 
  • Comparability Protocols
    Evaluation of structure-activity relationships (SAR) and their ties to manufacturing process parameters (e.g., Quality by Design evaluation)  
  • Chemistry, Manufacturing, & Controls (CMC) Reports
    Prepare process and product development reports, batch analyses, annual product reviews, stability analyses, justification of specifications, and more   
  • Protocols & Clinical Reports
    Protocol development and report writing, as well as pivotal support of clinical programs (e.g., establish clinical file databases, investigator documentation, and clinical trial material (CTM) accountability procedures)  
  • Quality Assurance (QA) Support
    QA support that evolves with your program, be it audits, document review, or SOP systems.  
  • Investigator's Brochures & Informed Consents
    Prepare clinical documents for investigator and site use  
  • Controlled Substances Compliance
    Audits, SOPs, and training for full compliance per 21 CFR 1300.

The whole package ... and more

If you require it, we can provide a customized turnkey operation with only the elements you need.

One-stop-shopping isn't just for home improvement stores.  It has become the new business model for contract pharmaceutical operations.  The down side is that you pay dearly for the overhead costs at those large CROs & CMOs when you only need a fraction of their services.  You could drive down the 'development highway' in a Humvee bus but you are going to pay dearly for all that gas.  Why not put your critical funding to the most efficient use?  Less is more ... and a whole lot easier to manage.