CMC Technical Solutions

Elevating Pharma Success: Guiding Innovation, Navigating Compliance.

How we support you

We build the foundation and add the Building blocks to provide a successful regulatory strategy for your product

Development

Whether you are innovating or optimizing your formulation and process, we are your oversight.

Clinical Trials – Phases 1 and 2

Early phase products benefit from solid experience in regulatory strategy. We understand phase-appropriate requirements.

Phase 3 and Registration

Your fully developed product will be managed with appropriate care. Gap assessments, risk assessments, and appropriate overall strategy prior to validation is a necessity.

Commercial Production

We support proven acceptable range (PAR) studies to assure continual improvement for approved products and stand by your side during manufacturing to ensure consistently safe and effective products are on the market.

Our Services Tailored To You

We’ve used our experience in the industry to meticulously tailor our services to assist your pharmaceutical corporation in fostering your path to innovation and regulatory excellence.

Specialists Eagerly Looking to Support You

Experience unparalleled expertise and dedicated support as our specialists work diligently to empower your pharmaceutical endeavors

Our Goal: Getting your product through the submission process with 20 observations

At CMC Technical Solutions, we believe in working with you to make navigating the submission process that much easier.

Working directly with our clients grants us the ability to give you personally tailored feedback to help solve your problems

Individual focus

Committed team