Continuous manufacturing (CM) is transforming how medicines are developed and produced. When aligned with your product’s needs, CM can improve quality, reduce costs, and shorten time to market. Success depends on tailoring implementation to your molecule, generic, OTC pathway, or CDMO client.
Pharmatech Associates, a USP company, brings science-backed CM guidance and decades of consulting expertise to help you build confidence. Our experts have designed and deployed continuous processing equipment for over 20 years, with a globally unmatched track record of success that lets us anticipate and avoid common pitfalls, from equipment and process perspectives to regulatory and quality standpoints. Often, the business case is the first hurdle; we leverage proven case studies and analyses to showcase C-level and Board-level benefits, including total cost of quality reductions and enhanced portfolio/capital planning for existing and new operations. Our support spans business case development, process design, equipment selection, and implementation, quality assurance and regulatory strategy and submission support.
Every product presents unique CMC and manufacturing challenges. We work with you to design CM strategies that anticipate risks and create value across development and commercialization.
What you gain:
Batch processing is getting more to its limits with increased automation efforts, leaving out the opportunities of process intensification for the early stages of product development.
Our support includes:
With todays in-silico modeling capabilities we, at PAI, support your PCM implementation process on multiple levels:
To name a few but established and proven modeling activities we can offer today.
If quality issues are slowing your program, CM can provide a solution. We assess your processes, identify bottlenecks, and guide implementation to ensure reliable outcomes.
Services include:
As environmental regulations tighten, sustainability is no longer optional. CM reduces waste, energy use, and variability while ensuring quality and compliance.
We help you:
Pharmatech Associates, a USP company, partners with you to create a CM strategy that reduces risk, improves quality, and accelerates market entry.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
510.732.0177
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
