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.

 

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.

EstiDATA

Complex pharmaceutical modeling – made easy.

TechTRANSFER

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”

AMPAC

“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

Understanding The Drug Development Life Cycle And Its Importance In The Pharmaceutical Industry
Pharmaceutical Development
April 23, 2022

Understanding the Drug Development Process and Its Importance in the Pharmaceutical Industry

The drug development process is long and complicated, but it's necessary to create effective treatments. Here's a look at what it entails.
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Industry's Quality Assurance
Pharmaceutical Industry
April 18, 2022

Quality Assurance in the Pharmaceutical Industry

Table of Contents The System of Quality Assurance Quality Assurance Goals Pharmaceutical Quality Assurance (QA) is a continuing process, a state of mind, and a working understanding of the standards and guidelines that apply to the development and manufacture of pharmaceutical products. Quality Assurance is a component of quality management which is committed to ensuring all laboratory operations are carried out in a precise and dependable manner. A drug must be both safe and effective to be approved for marketing. Performance has to be constant and predictable in order to be considered “successful”. Furthermore, QA can be described as the total of all actions and duties necessary to guarantee the drug delivered to the patient is safe and effective. The System of Quality Assurance Quality control, manufacturing, distribution, and inspections are the key areas of responsibility for this department: Quality Assurance ensures the necessary preparations have been made to manufacture, deliver, and use the proper starting and packaging materials. Any…
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Analytical Method Development and Validation A Brief Overview
Pharmaceutical Development
April 7, 2022

Analytical Method Development and Validation: A Brief Overview

Table of Contents What Is Analytical Method Development? Analytical Method Development Requirements Analytical Method Development Validation What Is Analytical Method Development? Analytical method development and validation are continuous efforts which include R&D, quality control and validation. Analysts are vital in assessing and managing equivalence and risk; it helps define product-specific acceptance criteria and ensures results are consistent. Validation should demonstrate the analytical process's suitability. Analysts can use it to characterize and optimize analytical procedures. Analytical procedure development and validation may significantly improve accuracy and reduce bias errors. Analytical Method Development Requirements Analytical chemistry uses modern technologies to determine a substance's makeup. We can produce quantitative and qualitative results. Analytical equipment is crucial to obtaining reliable data. Everyone in the lab should care about equipment quality. The technique may be spectroscopic, chromatographic, electrochemical or hybrid. Technique development involves creating an objective test to determine a formulation's composition. It is the process of proving an analytical technique which is acceptable for use…
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