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

Pharmaceutical Research Advances and Innovations
Research
January 15, 2022

Pharmaceutical Research Advances and Innovations

Table of Contents Pharmaceutical Research and Development Costs of Development Live Testing Pharmaceutical Research and Development While today's culture routinely misleads us into believing that money is the only key to happiness, the majority of us are aware that there are a plethora of other methods in which we might become prosperous. Our health becomes our number one concern as soon as we or someone close to us is afflicted with a disease or suffers a serious accident. The United States is fortunate in that we have access to a variety of pharmaceutical medications that may assist our bodies' immune systems in fighting sickness and allowing us a greater chance of recovery when we are sick. The United States has long been a pioneer in pharmaceutical research and development. Many bright scientific minds are attracted to the country to work at the forefront of pharmaceutical advancement and innovation. Because of state-of-the-art facilities, cutting-edge technology, and…
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Development and Validation of Pharmaceutical Analytical Procedures
Pharmaceutical Development
January 8, 2022

Development and Validation of Pharmaceutical Analytical Procedures

Table of Contents Method Development and Validation for Pharmaceutical Analytical Methods Data Quality Method Development Guidelines and requirements According to Validation of Analytical Procedures Method Development and Validation for Pharmaceutical Analytical Methods In order to protect customers' health and safety, analytical procedures must be thoroughly tested. Validation of analytical methods on pharmaceutical products is a requirement of current Good Manufacturing Practices (cGMP). Validation of data collection methods for pharmaceutical manufacture and regulatory filing is also required before their use. Validated analytical procedures aid in drug characterization, quality control, and batch-record keeping. – Method performance may be verified, and results in quality and reliability are ensured thanks to this analytical test method validation procedure, which provides documentation that the test methodology is appropriate for its intended purpose. Data Quality There are several steps that go into producing consistent and trustworthy quality data, including test technique validation. Analytical instrument qualification, a collection of documented evidence that the…
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Benefits and Validation Protocols of Pharmaceutics Process
Pharmaceutics Process
January 1, 2022

Benefits and Validation Protocols of Pharmaceutics Process

Table of Contents The Benefits of Pharmaceutical Process Development Pharmaceutical Consulting Pharmaceutical Process Validation Protocol Process Validation Protocol   The Benefits of Pharmaceutical Process Development In pharmaceutical process development, various tests and procedures are used to guarantee that your company is operating at its optimal efficiency. The majority of pharmaceutical companies seek outside assistance from pharmaceutical consulting services in order to help their businesses achieve maximum efficiency at the lowest feasible cost and in accordance with all relevant laws and regulations. Companies that specialize in pharmaceutical consulting may help with anything from product development and production to finance, distribution, marketing, and program management for each product or firm they work with. Just some of the services offered by pharmaceutical consulting companies include process development, validation, and stability testing. This means that they can assist you in reducing your pharmaceutical firm's production and distribution expenditures in order to ensure that your company is functioning at maximum…
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