LabCore
LabCore is an EMA accredited CRO, specializing in chromatography-related method development and method validation services including work with highly potent substances. We have permission to work with THC. Our expertise helps you get your analytical methods ready for QC or marketing authorization rapidly and economically. Our vision is to provide a helping hand in reducing the time and costs needed for the launching of new drugs on the market.
LabCore is designated to expand its analytical services in the pharmaceutical Industry, steadily transforming into a one-stop shop for pharmaceutical/biopharmaceutical analytics.
EMA accredited CRO
Handling with HPAPI
Working with THC
What we do
LabCore is a company whose core values are precision, accuracy, high quality and high adaptability to our partner’s needs. We offer our customers a boutique-like approach to co-designing the best services for their specific requirements. We have the knowledge to support big pharmaceutic companies in all fields of method development and validations and offer support for their research—our forte.
PHYSICAL AND PHYSICOCHEMICAL TESTING
- Raw materials
- Finished products
- Packaging
- Identification
- Assay
- Test for related substances
- Dissolution
- Stability
RESEARCH & DEVELOPMENT
- Method development
- Validation/Verification
- Method transfer
- Custom synthesis
- Research
We are offering method development, validation/verification and transfer of all applicable methodologies used in pharmaceutical analytics.
Additionally we are offering research services in the field of synthetic chemistry, such as synthesis and characterization of impurities and synthesis of standards, possible API development, etc.
Furthermore we are always opened for new collaboration opportunities in the field of pharmaceutical or chemical related science.
Custom synthesis
We provide custom synthesis of organic compounds from milligram to kilogram quantities. We are specialized in synthesis of process impurities, custom building blocks, specialty chemicals and libraries of research chemicals for screening of biological activities.
Development of novel routes of synthesis, including optimisation of syntheses, laboratory scale process development, identification of impurities and their synthesis is another service we offer.
Nitrosamine impurities
One of the many services that we offer is determining nitrosamine impurities and synthesis of nitrosamine analytical standards. As we strive to keep pace with the industry, we have also focused on nitrosamines, which became a factor for endangering human lives if they exceed the maximum allowed levels approved by the FDA.
We have developed an in-house method to determine extremely low levels of nitrosamines using the required LC MSMS and GC MSMS equipment to ensure that your drugs meet all the requirements and are safe for users. We can synthesize nitrosamines of amines present in API manufacturing processes for use as analytical standards.
As we know this is a big problem in the industry, we are also focused on research into where in the production line of drug development these impurities occur and are open for collaboration.
About us
For smaller companies, we offer a complete approach to their needs. From our collaborations so far, we understand the products of our customers and can also contribute to their understanding of the regulatory requirements, especially for companies just entering the field or those who would simply like to add value to their products. We can also provide services for companies specialising in products made from Cannabis sativa, as we have a permit to work with illegal substances.
In addition to all the above, we closely follow the food supplements industry and regulations as we know a poorly regulated sector will soon have to meet higher standards to ensure proper safety for consumers. We are here to help your products meet these higher standards. We are looking forward to becoming your go-to solution.
LabCore is a company whose core values are precision, accuracy, high quality, and high adaptability to our partner’s needs. We offer our customers a boutique-like approach to co-designing the best services for their specific requirements. We have the knowledge to support big pharmaceutic companies in all fields of method development and validations and offer support for their research – our forte. For smaller companies, we offer a complete approach to their needs. From our collaborations so far, we understand the products of our customers and can also contribute to their understanding of the regulatory requirements, especially for companies just entering the field or those who would simply like to add value to their products.
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