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

Justin Cesnavicius 0
0
Uncategorised
June 7, 2024

Big Data Meets Big Pharma

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…
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Brian James 0
0
CMC Consutants, Gmp,Good,Manufacturing,Practice,Medicine,Pharmacy,Сoncept.,Quality,Control,Standards
CMC ConsultingPharmaceutical ConsultantPharmaceutical Development
February 23, 2023

Who Needs CMC Consultants? You do.

The pharmaceutical industry is a highly regulated field that requires attention to detail at every stage of product development. The Chemistry, Manufacturing, and Controls (CMC) aspect of drug development is critical, as it involves ensuring the safety, quality, and efficacy of the final product. CMC consultants are professionals who specialize in providing expert advice and guidance in this field, and they can be an invaluable asset to pharmaceutical companies throughout the development process. Regulatory Compliance One of the primary benefits of hiring a pharmaceutical CMC consultant is their expertise in regulatory compliance. The pharmaceutical industry is heavily regulated, and there are numerous guidelines and regulations that companies must adhere to in order to bring their products to market. CMC consultants are well-versed in these regulations and can help companies navigate the complex regulatory landscape, ensuring that their products meet all the necessary requirements. Cost-Effectiveness Developing a new drug can be a costly and time-consuming process. Pharmaceutical CMC consultants can help…
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