Our customized solutions span early discovery and development through scale-up to commercial manufacturing. At every stage, Kumidas delivers the following three types of custom services for your choice:
Custom Synthesis and Contract Manufacturing
We can properly handle the synthesis of custom compounds in grams to kilos or larger amounts, either cGMP or non-cGMP through our own facilities and validated manufacturing partners. our team will properly evaluate and select the best way to realize your objective. We have a good record of success in performing expeditious synthesis campaigns under tight timelines.
• Reagents, building blocks, Intermediates and APIs unlisted in our latest product catalogue (available at the bottom of this webpage);
• Bulk quantities of our products;
• Scale-up for your own developed products utilising similar reactions or new synthesis pathway;
• Hard to find, rare and novel fluorochemicals or non-fluorochemicals;
Our process development scientists aim to develop and optimise the performance of manufacturing systems from route scouting, laboratory development to pilot and industrial scale. They are responsible for identifying and developing new processes for product manufacture, as well implementing process controls to make sure the products are of a high quality and are manufactured in a reproducible manner.
• Synthetic route selection and experimental research design;
• Process Development, Verification and optimization through continuous improvements;
• Technology transfer of processes from pilot to production;
• Impurity characterization, including identification, quantification and tracking;
Our experienced team routinely offer end to end solutions for analytical testing services of compound, product & packaging attributes and regulatory affairs support to meet your batch release, stability, quality control testing needs and regulatory compliance.
• Starting material selection;
• Impurity control strategy;
• Quality specification set up;
• PGI assessment;
• Elemental impurity assessment;
• CMC writing
• Regulatory strategies for the filings of starting material, advance intermeidate and API;
• Response to waring letters from health authorities.
How we proceed with your inquiry?
The normal quotation process for handling your request is shown as followed:
Step 1: Request for Proposal (RfP) :
Please complete theCustom Solution Inquiry Formas much detail as possible. If it isn't easily fit your special requirements, please contact us directly.
Step 2: Confidentiality Agreement (CDA) : A formal confidentiality agreement can be arranged before you disclose any detailed information.In any case, confidentiality will follow the highest standards all through the process of custom solution.
Step 3: Service Proposal : Shortly after the CDA is signed by the involved parties, our team will be exploring and preparing a detailing proposal for the custom service (custom synthesis/contract manufacturing/process development/ analytical service and regulatory support) you need.
Step 4: Quotation from Kumidas : Contract is based on a fixed-price quotation, or for larger project can be arranged on a FTE/FFS basis to create a flexible and interactive collaboration.
Step 5: Custom Solution Service :
Once our quotation is accepted by customer, we will commence the custom solution process accordingly. To guarantee in-house quality control and on-time delivery date, we will provide weekly or bi-weekly updates on project progress for fixed price quotes and regular client communication for FTE/FFS projects.
Please inquire for pricing and availability of custom compounds by writing email to email@example.com.