Rondaxe Pharma’s CMC solutions, global regulatory strategies, drug development, and manufacturing helps emerging and specialty pharmaceutical companies with cost, data management, analyses, and other operations.
Rondaxe Pharma assists multinational pharmaceutical clients and virtual pharma/biotech companies in developing and formulating products through commercial manufacturing. As one of the largest and most experienced international pharmaceutical companies worldwide, it boasts a team of experts in analytical development, chemistry, route scouting, manufacturing/distribution, and drug product commercialization. The group stays up-to-date with technology, medical advancements, customer needs, and development risks/challenges to maintain high-quality standards. The team includes subject matter experts and service providers who ensure service providers and partners clients select are fit-for-purpose and adequately priced no matter the stage of development.
Rondaxe Pharma’s CMC consulting software provides manufacturing strategies and drug development to the industry, especially emerging and specialty pharmaceutical companies. It runs on the skills of a diverse group of former senior managers and former directors with expertise in chemical development, quality assurance, regulatory affairs, drug product development, and analytics. The company’s pharmaceutical consulting uses proprietary systems and databases for process research/development, manufacturing operations, supply chain strategies, quality control, fermentation, and biocatalysis development.
Companies desiring to decrease costs, confusion, effort, frustration, and complex pharmaceutical modeling can adopt the EstiDATA Cost-of-Goods software. It offers financial modeling for compounds and products, allowing users to determine the cost of processes after considering variables such as supply sources, facilities, and material prices. The EstiDATA API synthesis, drug product, and biologics create an economics model, support drug product estimates, establish a consistent basis for comparison, and connect the pieces for software users, managers, and executives.
The process begins when a user enters specific data and makes worksheet calculations or builds scenarios. From there, they can derive sensitivity analyses and cost ladders that change impact and determine key cost drivers of a specific manufacturing process. The software comes with an extensive Price Advice Library, regularly updated with solvent, facility overheads, waste disposal fees, and packaging components for manufacturing costs.
The TechTRANSFER platform streamlines and standardizes the tech transfer process so companies can focus on the issues that matter. As a web-server-based application that saves money and labor, it facilitates the accumulation and accurate transmission of process information. Users can create a chronological description/recipe of storage/data processing using defined materials, action words, parameters, and equipment. Companies mitigate risk, improve communication, increase speed, and reduce errors by providing consistent and rapid coordination of information between all users. Check out their website to learn more about Rondaxe Pharma.
Since its founding in 2001, the company’s industry experts and project managers have worked alongside clients in process development, negotiations, agency interaction/filings, commercial supply chain management, and many more. Additionally, they understand the regulatory implications of process and development decisions to participate in meetings with the FDA and other regulatory bodies. They can assist clients in the robust evaluation of current/prospective service providers and overall manufacturing processes/strategies for assured quality/full compliance.
To book a discussion/demo, call 315-469-2800. Rondaxe Pharma is at 6443 Ridings Rd #125, Syracuse, New York, 13206, US.
6443 Ridings Rd #125
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