Avoid common risks inherent in life science projects. Our process ensures better data capture, reduced cycle time, and relevant technology transfer.
Technology Transfer
Process Scale Up
Transitioning between the lab and the plant requires the know how to ensure your clinical supply is not put at risk. Let Total Synthesis evaluate your transition today.
Process Control Strategy
Whether manufacturing clinical batches or qualifying your process for commercialization, Total Synthesis has the experience in phase appropriate control strategies you need.
Facility Design
Expanding or updating you manufacturing space? Our team has hands on experience in full facility expansion and HPAPI suites.
FMEA
Total Synthesis has what you need to investigate the failure modes for your process and equipment. Let our engineers provide a fresh perspective ensuring your process is protected.
API Manufacturing Support
Total Synthesis has the tools to support you and your manufacturing partners during your manufacturing campaign.
Process Development Support
Specification Development
Let our experts help in designing phase appropriate specifications for your process. We will balance the constraints ensuring quality product without over specification. Developing phase appropriate specification as the data set grows and putting plans in place to ensure you are ready for filling specifications.
Design of Experiments
Intelligent experimental design can be the difference between failure and success. Let Total Synthesis help ensure your project is operating in known territory.
Design Space Identification
How much of your acceptable operating range can be utilized for the normal operating range? Working together we can ensure that the manufacturing tolerance is more than a fine line.
Project Management
Construction Management
Expanding or Renovating? Our team has the experience in both, with our hands on experience let us save you from the headaches.
CDMO/CRO Management
Struggling with your manufacturing partner? Having been on the inside, Total Synthesis can help you get the best out of your partners.
Resource Planning
Ensure your timelines are based on data rather than projections with Total Synthesis.
Quality
Process Performance Qualification
Gearing up for NDA filling is a monumental task, let our experts help ensure you are balancing the need to specify and over specification.
Equipment Validation
Equipment validation is an important regulatory component, but these steps do not move your business forward. Let Total Synthesis take care of the details.
Design Assessment
From setting design specifications to constructing test cases, let us help you test your product to make sure it operates as intended.
GMP Consulting
Let total synthesis assess your quality systems. Our professionals will provide valuable feedback protecting from costly compliance violations.
Operational Excellence
Workflow Optimization
Let our fresh eyes eliminate waste. We don’t believe in the “that’s how we have always done it” philosophy. Together we can ensure non-essential tasks are eliminated.
SOP Development
Quality standard operating procedures are essential to operational uniformity, deviation reduction, and compliance. Our team will ensure the real procedure is captured in your documentation avoiding costly compliance violation and improving operator comprehension.
Operation Training Programs
Uniformity across operations ensures the systems and documentation perform their intended functions. Let us help you align your training documentation and systems.
LSS Philosophy
Reduce waste and improve processing time with the implementation of Lean Six Sigma at your site.
Clinical Development Support
Biostatistics
With decades of experience in biostatistics in both basic science and clinal research studies, Total Synthesis has the team to digest and analyze the data for you.
Study Design
Total Synthesis has the team to assist in the design or review of your clinical research studies ensuring Intelligent study design and advancing your mission.
Grant Application
The team at Total Synthesis has the experience to review your grant application increasing the probability of advancing your discoveries.
Don’t see what you are looking for? Reach out to see if our team can help you succeed.
Make Your Project a Success
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