Do you need extra support for regulatory submission studies?
If a product is required for regulatory submission, we include detailed documentation on all aspects of the labelling project. This service is referred to as Regulatory Submission Work (RSW). It is further supported by laboratory visits and audits, which are often requested and easily accommodated.
We pride ourselves on our high level of service. From the initial consultation, through thorough analysis, to delivery of the final product accompanied by supporting documentation, our custom labelling team provides confidential custom preparation work for high-quality carbon-14 and tritium labelled compounds.
Standard Specifications for RSW work:
- All RSW work is carried out in accordance with the requirements of the RSW manual and Standard Operating Procedures (SOP).
- Dedicated enclosures are used for RSW work. These are cleaned, prepared, and controlled in accordance with documented procedures.
- Raw materials associated with RSW work are purchased specifically for the individual preparation and are supplied with Certificates of Analysis where available.
- Raw materials are quarantined during the preparation.
- Radiochemical purity of the product is > 98% (unless contractually specified). The customer supplies the method of analysis.
- Chemical purity of the product is > 98% (unless contractually specified). The customer supplies the method of analysis.
- A full synthetic write-up and chemical schematic is provided.
Additional options for RSW work:
- Raw material analysis is undertaken where possible. This will usually be by either NMR or IR spectroscopy.
- A copy of the laboratory file detailing the full preparation from standard radiochemical intermediates is provided.
- The preparation is audited by Quality Assurance against the RSW manual, all relevant SOPs, and any additional customer requirements. A report is copied to the customer.
- Quality Assurance formally releases the product.
- Stability studies are implemented.
Let us know what your requirements are! Request a quote.
Do you have more questions? Visit our FAQ's section.
See how our preparations have been used in many different areas. Visit our literature section.
Contact us, to speak to a custom label representative.
*Only available in North America | 
