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August 17, 2021
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   GMP Carbon-14 Labeled API Manufacturing

Moravek is recognized internationally as a leading provider of GMP carbon-14 labeled APIs for use in early-phase clinical trials. Over 100 GMP APIs have been produced in compliance with FDA guidance, and all have successfully met client, CRO, and regulatory requirements.

Moravek offers outstanding CDMO capabilities and has substantial experience seamlessly coordinating concurrent progress of both CDMO and CRO activities.

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» Industry News
 
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» Featured Articles
How Real World Data, Decentralized Trials, and Diversity Will Put the Patient First
It has been nearly a year since the U.S. government introduced Operation Warp Speed (OWS). The public-private partnership has surely been imperfect during the quest to develop, manufacture, and ... read more »
Achieving Clinical Trial Diversity Through Actionable Steps
The medical community and cultural opinion agree: clinical trials need diversity. It’s our job to serve affected populations, but we cannot do that if we don’t have an appropriate representation of ... read more »
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» Featured Partners
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  Discover the end-to-end expertise of the CDMO formerly known as AMRI

For decades, Curia—formerly AMRI—has accelerated our partners’ work, from research and development through commercial manufacturing. Together, we can turn life-changing potential into life-changing progress. read more »
» Featured Video
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  On-Demand Webinar: New Strategies to Enhance Physicochemical Characteristics of Active Pharmaceutical Ingredients
In this webinar you’ll learn about API polymorph landscape, salts, and co-crystals screening. You will also hear about new solid form developments and regulatory guidelines around it. read more »
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  On-Demand Webinar: The Pitfalls and Strategies for Pediatric Formulation Development
In this webinar you’ll learn common issues and strategies for pediatric formulations development as well as some of the various resources and regulatory bodies; Impact of age group, daily dose, and ... read more »

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» Featured Whitepaper
Drug Substance & CMC Development Tool Box: Selection of cGMP Starting Materials (RSMs)
cGMP Starting Materials (Regulatory or Registered Starting Materials, ‘RSMs’) represent the formal start of cGMP (current Good Manufacturing Practice)... read more »
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| Events
EVENT
  Validation Week
Philadelphia, PA and Online –  10/19/2021
The gold-standard event for quality and validation professionals, prepare to zero in on proven strategies for achieving regulatory compliance and ... event details »
EVENT
  Compounding Pharmacy Compliance East
College Park, MD and Online –  11/08/2021
Industry’s leading event for compounding professionals, Compounding Pharmacy Compliance East returns in a hybrid format, in-person November 8-10 in ... event details »
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