Your partner in navigating the

CMC Drug Development Path

Key Capabilities

CMC Turnkey Solutions is dedicated to providing Regulatory, Technical, Quality, and Business expertise to drug development clients in the pre-IND, IND, and NDA/BLA stages of development. We tailor our services to each client individually to ensure every client receives the level of support they need to be successful in their clinical programs and regulatory submissions. 

Program Management Expertise

Strategic and technical support in the following areas:

Technical Operations

CMC Subject Matter Expertise

Quality Operations

Quality and Regulatory Expertise

Business Operations

Strategic and Leadership Expertise

Learn More Here

Testimonials

What our clients are saying about us
  • CMC Turnkey was pivotal in helping our company navigate through multiple stages of biotherapeutic product development, establishing a quality system, and building a GMP-compliant manufacturing facility.  Their expertise in CMC greatly expedited the preparation and submission of our first IND. 

    David Infanger, Ph.D.

    Vice President, Research and Development, SilkTech Biopharmaceuticals, Ltd.
  • I have been working alongside Audrey and CMC Turnkey Solutions on ophthalmic product development programs since 2019. Audrey and her team are smart, experienced, have excellent attention to detail, and they just get things done. Plus, they are fun to be around, even when things don’t go as expected!  I highly recommend CMC Turnkey Solutions for anyone looking to have an experienced CMC group in their corner.

    Rose Verhoeven, MTox

    Little Creek Research
  • Audrey Schupp is commanding, thorough, meticulous, timely, and insightful. CMC Turnkey Solutions has been indispensable in the execution of my project.

    Martin Uram, MD, MPH

    CEO, Founder, Vitreoretinal Specialist, American Genomics
  • PharmaLogic has worked with CMCTKS starting in early 2018 on numerous ophthalmic investigational products – from anterior to posterior segment. This work included product development and manufacture, face-to-face regulatory meetings, and regulatory filings. I highly recommend CMCTKS for a broad range of CMC support.

    Gary Novack, PhD

    President, PharmaLogic Development, Inc