Consulting Services
There are times when training alone is not enough. Thomas A. Little Consulting offers a complete suite of consulting services uniquely tailored to meet customer specific needs. TLC participates with the company to assist in many of the Quality by Design related tasks including quality risk management, study design, analysis and report generation.
TLC consultants have individually 20+ years of industry experience and provide assistance to organizations so that they can comfortably transition into modern drug development methodologies and ensure they meet expectations when submitting information to the various regulatory agencies. TLC helps to augment and build on current organizational capabilities and provide surge capabilities when working on tight timelines or knowledge deficits. Support can either be on-site or remotely via WebEx or other telecommunication tools.
The following are specific areas of experience and expertise. Please contact us to provide quotations or more details on any of the items below. If you need help on something that is not included below, just ask for a quotation and we will let you know if it is something we can assist you with.
Study Design and Analytics
- CQA generation
- Experimental and characterization developmental strategy
- CAPA and Root Cause Analysis
- Upstream processes
- Downstream processes
- Formulation and Mixture DOE
- Stability by design
- Device related processes
- Design of Experiments and Multivariate Analysis
- Design space generation and NOR/PAR ranges
- Potency Assays and Nonlinear modeling
- Method Validation and accuracy to precision modeling
- Dissolution Profiles
- Accelerated and long term stability design and analysis
- Tolerance design and specification setting
- Comparability and Equivalence evaluation
- Master Validation Plan
- Sample size selection
- SPC/PAT control design
