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

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Drug Development Stages
Pharmaceutical Development
October 25, 2022

What Are the Drug Development Stages?

Table of Contents Development and Discovery Pre-Clinical Testing Clinical Research FDA Review Thousands of medications are on the market, and new ones are being developed continuously. With so many medicines already on the market, getting one on the market may seem simpler. Developing new drugs, on the other hand, is a big job. We have blogs that talk about the importance of each development step, including the advantages of post-approval research and development. This rigorous procedure ensures that drugs are effective and safe enough to be available to many people. But what precisely must be done to create new drugs? The drug development process can be divided into 4 parts. These phases contain all that must be done to bring new medications to market, from early research through FDA approval. The 4 stages of drug development are summarized here: Development and Discovery The discovery process is the initial stage in medication development. New illness therapies may be discovered when new…
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Drug Formulations and Conducting Clinical
Pharmaceutical Development
October 18, 2022

Developing Drug Formulations and Conducting Clinical Trials

Table of Contents What Is Drug Formulation? Why Is Drug Formulation Development Important? What Should Be Considered While Developing a Formulation? How Many Drug Dose Types Are There? What Are Early-Phase Formulation Challenges? Why Should Biotechs Outsource Drug Formulation? Biotech companies making new drugs to be tested in first-in-human (FIH) clinical trials face a big problem with how to make the drugs. Formulation development is important in the early stages of drug development, and for how well a promising investigational medicinal product will do on the market in the future. What Is Drug Formulation? Drug formulation, also called “pharmaceutical” formulation, combines different substances with the drug's active pharmaceutical ingredient (API) to make a drug product that can be given to patients safely. Why Is Drug Formulation Development Important? Formulation development is very important because it involves ensuring a drug is prepared and taken in a safe and good way for the patient.  In 2018, a survey was done to determine…
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Role of a Pharma Consultant
CMC Consulting
October 11, 2022

What Is the Role of a Pharma Consultant?

Table of Contents What Exactly Is Pharma Consulting? What Role Does a Pharma Consultant Play? When was the last time you needed medication? Perhaps you recently took some painkillers after a difficult workout, or you needed something to treat the flu? Most of us are unaware of the amount of research, clinical trials, and financial commitment to bringing various pharmaceuticals to market, since they are so easily accessible. Numerous scientists, researchers, C-suite executives, and pharma consultants are required to enhance medications and medical equipment, readily available to most of the population. This article focuses on the role of pharmaceutical consultants which you should know. What Exactly Is Pharma Consulting? Pharmaceutical consulting is a broad category of experts that mostly assist pharma and biotech companies in the development and commercialization of drugs. This specialty offers possibilities for seasoned professionals with specific talents in a range of fields, including as strategy and commercialization, product development, and business development. In contrast to other…
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