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

Jason Kaimana 0
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cancer, technology, chemotherapydisease, researchPharmaceutical Development
December 6, 2024

Drug Development Trends of 2024

Recent advancements in technology have significantly impacted the drug development process. Increasingly advanced and powerful tools have shifted the focus of primary drug activation as well as which diseases are gaining attention. Rare Diseases Rare diseases have become a greater interest to manufacturers due to scientific advancements and regulatory incentives. The Orphan Drug Act has included incentives such as extended exclusivity periods, tax credits, and waiving of FDA fees, leading to a large number of drug approvals focused on rare diseases. These and other incentives have made rare diseases faster and more accessible to pursue, resulting in an explosion of interest from pharma. Advancements in genomics and bioinformatics have improved our understanding of the mechanisms of previously neglected diseases such as malaria and TB. While these diseases have not received as much attention in the past due to complexities in drug discovery, advanced technology has provided the opportunity for targeted therapies with longer market exclusivity and higher prices. Companies such…
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Jason Kaimana 0
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BusinessPharmaceutical IndustryRegulatory
November 5, 2024

Outsourcing Trends in 2024

Outsourcing Trends & Strategies in the Pharmaceutical Industry Outsourcing is essential in the pharmaceutical industry, driven by the needs for cost reduction, operational efficiency, and access to specialized expertise. Understanding the latest trends and implementing effective outsourcing strategies is crucial for maintaining competitive advantage and ensuring sustainable growth. Current Trends in Pharmaceutical Outsourcing Focus on Quality and Compliance Maintaining high standards of quality and regulatory compliance is a top priority for pharmaceutical companies. Outsourcing partners must adhere to stringent regulatory requirements to ensure product safety and efficacy. This has led to increased scrutiny and more rigorous selection processes for choosing outsourcing partners, particularly regarding their regulatory experience, inspection histories, and perceived ability to handle the complexities of the approval process. This latter point is amplified by regulatory differences among nations, given the necessity of global clinical trials. Increased Reliance on Contract Development and Manufacturing Organizations Pharmaceutical companies are increasingly partnering with CDMOs to handle various aspects of drug development and…
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Jason Kaimana 0
0
Pharmaceutical IndustryRegulatory
September 19, 2024

Regulatory Landscape 2024

Recent trends in the regulatory landscape and healthcare could significantly impact the pharmaceutical industry. Expansion of Therapeutic Modalities: The modality landscape is broadening beyond traditional small molecules and proteins to include peptides, antibody-drug conjugates, nucleotide-based therapies (especially antisense oligonucleotides, siRNAs, and mRNAs), radionuclides (theranostics) and cell and gene therapies. This diversification brings new preclinical and drug development requirements and additional regulatory complexities.  For example, the complexities of bringing a radionuclide to market are amplified when regulatory agencies must cope with the fact that most radioactive therapeutics need to be used within one week – and often the same day – that they are manufactured.  These requirements necessitate regulation at the level of the radionuclide generator itself (68Ga and 99mTc) or as radionuclide precursor formulations (177Lu, 111In, 64Cu, 90Y) due to the sophisticated infrastructure involved. Increased Focus on Digital Technology: Regulatory changes in 2024 aim to clarify technology and data collection rules. This includes updates to the International Council for Harmonisation's…
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