Frequently Asked Questions

Rondaxe offers comprehensive Chemistry, Manufacturing, and Controls (CMC) consulting, drug development strategies, manufacturing support, regulatory guidance, and proprietary software solutions to pharmaceutical and biotech companies.

Rondaxe collaborates with companies of all sizes from virtual pharma/biotech startups to large multinational pharmaceutical companies, assisting them from early development stages through to commercial manufacturing.

Rondaxe provides guidance on regulatory strategies, assists with the preparation of regulatory documents and applications, and ensures clients meet global regulatory requirements.

EstiDATA is Rondaxe’s proprietary software that offers cost estimation and financial modeling for pharmaceutical active ingredients, biologics, or drug products, helping clients make informed decisions about manufacturing processes.

SimpliDATA is Rondaxe’s platform designed to streamline and standardize the technology transfer process, ensuring efficient coordination of information and reducing errors during product development.

To ensure a robust supply chain, Rondaxe offers end-to-end supply chain assessment and optimization, vendor selection and management, cost of goods evaluation, and contingency planning.

Yes, Rondaxe’s analytical development team provides comprehensive methods development and validation experience, ensuring accurate and reliable analytical strategies for clients.

Rondaxe has extensive experience in biological and cell culture technologies, including cell line engineering, recombinant protein expression, and biotransformation processes.

Rondaxe has a structured approach to technology transfer, focusing on mitigating risks, improving communication, and ensuring consistent quality during the transfer of processes between facilities.

Rondaxe’s software solutions are designed to link with legacy document management systems, manage libraries of materials and vendors, and provide visual diagrams for process calculations, enhancing data organization and decision-making.

Rondaxe prepares and manages required SOPs for cGMP compliance, trains staff, executes quality agreements with contract manufacturers and many other Quality Assurance functions as requested.

Rondaxe offers training in cGMP policies and compliance, preparation for regulatory inspections, and guidance on responding to regulatory agency inquiries.

You can contact Rondaxe through their website at www.rondaxe.com, by phone at 315-469-2800, or via email at [email protected].