Pharmaceutical CMC
Consulting & Software

Rondaxe employs a diverse group of former directors and senior managers
from the pharmaceutical industry with expertise in chemical, fermentation,
drug product and analytical development and supply chain strategy.


Award Winning Software

When dealing with mountains of data the CentraDATA software can provide
context and structure, which is key to improving the challenging task of
bringing a drug to market.



Tech or technology transfer is a mature discipline that follows a
structured approach with predictable outcomes. Each type of tech
transfer project presents its own set of unique risks. We make sure transfer
protocols are developed to capture the process thoroughly.


Guiding You On The Drug Development Path To Success

Based out of New York, Rondaxe is one of the largest and most experienced international pharmaceutical development companies and CMC consulting groups in the world. We assist both virtual pharma/biotech companies and multi-national pharmaceutical clients from early development and formulation of pharmaceutical products through commercial manufacturing. Services include comprehensive CMC solutions, drug development, manufacturing and global regulatory strategies. [Re]source™ is our proprietary software that allows our clients to accurately and efficiently model Cost of Goods, perform should cost analysis, safely and accurately organize data for Tech Transfer and gives our users full transparency and traceability to simplify complex aforementioned tasks.

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Rondaxe CMC consulting group is focused on providing drug development and manufacturing strategies to the pharmaceutical industry.


Complex pharmaceutical modeling – made easy.


Streamlining and standardizing the Tech Transfer process.

Trusted By Some Of The Largest Pharmaceutical Organizations

Pharmaceutical companies across North America are benefiting from Rondaxe services

What our clients say

“AMPAC Fine Chemicals considers Rondaxe to be a ‘Key Skills Multiplier’ & have benefited from their support in critical strategic engineering and chemistry solutions. Additionally, their market knowledge & industry contact base prove to be of significant benefit to our business”


“Rondaxe Cost of Goods Software gives me a tool to quickly estimate manufacturing costs for intermediates and API, rigorously and reliably. The estimates are easy to understand and I can stand behind them when sharing with management or potential partners. Further, the output reports clearly highlight the key cost drivers and help my team focus their R&D efforts.”

Array BioPharma


July 24, 2023

BARDA’s Collaborative Approach: Strengthening Public-Private Partnerships

COVID-19 Vaccine Introduction: In an ever-evolving landscape of public health emergencies and biological threats, the importance of collaborative efforts between the public and private sectors cannot be overstated. Biomedical Advanced Research and Development Authority (BARDA), a component of the ASPR arm of U.S. Department of Health and Human Services, has emerged as a crucial player in fostering partnerships to advance the development of medical countermeasures. In this blog, we will explore how BARDA collaborates with both the private and public sectors to drive innovation and preparedness. Some examples will be provided to illustrate the diverse partnerships BARDA has established with the private sector to drive innovation, accelerate development, and strengthen manufacturing and distribution capabilities for medical countermeasures.  The examples below are a just a partial who’s who of BARDA collaborators: our hope is that they also serve to stimulate ideas for further collaboration. Private and Public Sector Collaboration BARDA recognizes that effective preparedness and response require bridging the gap between…
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June 21, 2023

Navigating the Shifting Regulatory Landscape

Introduction: In today's dynamic pharmaceutical industry, regulatory compliance plays a pivotal role in ensuring patient safety, maintaining public trust, and driving innovation. The regulatory landscape is ever shifting, influenced by emerging technologies, evolving global standards, and increasing scrutiny. It is crucial to stay informed about these transformations and adapt our strategies to navigate the shifting regulatory landscape effectively. This blog aims to provide insight into the changing regulatory compliance landscape and how it impacts the pharmaceutical industry.  We’ll first take a look at some broad categories of regulatory science that have been changed by recent advancements in technology, then dive into a few of the more interesting ones.  We’ll conclude with a really deep dive into a specific example from the private sector (Flatiron Health) and the public section (The FDA’s Sentinel Initiative) to bring home the way that innovation is accelerating regulatory science. Streamlined Data Handling and Accessibility: New technology allows for more efficient and streamlined data handling, storage,…
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May 24, 2023

Climate Change and Fungal Diseases: The Role of Environmental Factors

Candida auris fungi, emerging multidrug resistant fungus, 3D illustration Our Changing Climate The impact of climate change on global health is a growing concern, with recent studies indicating that rising temperatures, changes in precipitation patterns, and other environmental factors may be contributing to the emergence of new diseases. In particular, fungal diseases have become an increasing threat in recent years, with a number of new and deadly pathogens emerging in different parts of the world. Fungal diseases have been responsible for several clinically relevant outbreaks, including the recent emergence of Candida auris, a drug-resistant fungus that has spread rapidly across the globe. This and other new fungal pathogens have been linked to environmental factors such as deforestation, agricultural practices, and climate change. How Fungi Capitalize One key way in which climate change is thought to be driving the emergence of new fungal diseases is through change in temperature and precipitation patterns. As temperatures rise and rainfall becomes more erratic, the…
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