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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.

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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.

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TechTransfer

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.

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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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CMC

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

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EstiDATA

Complex pharmaceutical modeling – made easy.

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TechTRANSFER

Streamlining and standardizing the Tech Transfer process.

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Trusted By Some Of The Largest Pharmaceutical Organizations

Pharmaceutical companies across North America are benefiting from Rondaxe services

exelixis
stemline
outpost
dalcor
myo
biogen
dalcor
appili
spero
myovant
kary
glyco

What our clients say

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“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”

AMPAC
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“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

Blog

CAR-T cancer, technology, chemotherapyCustom Manufacturingdisease, researchgenetic sequencing,, drug development
February 18, 2025

CAR-T

Introduction: Chimeric Antigen Receptor (CAR) T-cell therapy is advancing cancer treatment with a personalized approach that reprograms a patient’s own immune cells to target and kill cancer cells. Originally developed for hematologic malignancies, CAR-T therapy has shown strong promise in treating otherwise difficult cancers. This therapy presents a unique opportunity for the development of novel oncological and immunotherapy drugs. T-cells are harvested from a patient’s blood sample, and a viral or non-viral vector is used to introduce the genetic instructions to create the CAR. The vector is a delivery system that introduces the CAR gene, enabling the cell to produce these specific receptors. After these trained cells multiply, they are reintroduced into the patient and multiply in the bloodstream. These cells are now able to detect cancer cells that have hidden from standard immune identification. Development: CAR-T therapy has evolved from a long lineage of immunotherapy milestones—from 19th-century bacterial-based approaches such as Coley’s Toxins and BCG vaccine studies to modern…
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The Rise of GLP-1 Drugs Custom Manufacturingdisease, researchgenetic sequencing,, drug developmenthealth, diet
January 16, 2025

The Rise of GLP-1 Drugs

The Rise of GLP-1 Drugs  Glucagon-like peptide-1(GLP-1) agonist drugs have emerged as one of the most significant breakthroughs in recent pharmaceutical history. Designed for managing Type 2 diabetes, these drugs have made news headlines and skyrocketed in popularity for their effectiveness in weight loss.   Transition from Diabetes to Weight Loss:  The GLP-1 hormone was first identified by researchers at Massachusetts General Hospital in 1986 as a glucagon precursor. This quickly found commercial applications for managing conditions such as diabetes with Novo Nordisk developing liraglutide in 1990s. This eventually led to the development of semaglutide in 2012, with a similar mechanism of action, but slower onset of effect and longer duration of action. Initially designed for diabetes treatment, the FDA approved Ozempic in 2017. Researchers noted in clinical trials that participants lost 10-15% of their body weight, prompting further applications for weight loss and obesity. Wegovy, another semaglutide-based formulation, uses a higher dose specifically for weight loss and achieved FDA approval…
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Big Data Meets Big Pharma BusinessData ManagementPharmaceutical Development
June 7, 2024

Big Data Meets Big Pharma

Burgeoning Data The amount of data generated daily has grown exponentially in recent history. According to an article by Fabio Duarte, almost 329 million terabytes of data are generated each day, totaling 120 zettabytes annually (1 zettabyte = 1,000,000,000,000,000,000,000 bytes). Sensors on manufacturing equipment generate data based on current conditions and equipment performance. IoT devices can process this data to make immediate adjustments for optimal performance, quality, and regulatory compliance. Processing this “big data” efficiently can be a major source of competitive advantage for pharma companies. Big Data Analytics Aggregated data generated by equipment-bound sensors can differ from the data found in traditional datasets and processed by analytical methods. Traditional analysis focuses on static data and historical trends but is less effective with high-volume, real-time data. Data veracity is vital to transforming data into usable information; big datasets have a huge pool of data to offset outliers and reduce human error during analysis. Big data frameworks like open-sourced Hadoop and…
Justin Cesnavicius 0
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