



GMP compliant cryo-TEM instills confidence in the quality and safety of your drug products.
Cryo-TEM is being used more frequently in drug development and biopharmaceutical research, and it is essential to ensure that the highest standards of quality and safety are maintained. This is where Good Manufacturing Practices (GMP) are a key to success.
GMP compliance is a quality control system which establishes procedures designed to ensure that products are consistently produced and controlled according to established quality standards. It is an essential requirement for facilities involved in the manufacturing and testing of drugs and pharmaceuticals.
As a GMP-compliant cryo-TEM facility, NIS ensures that the highest standards of quality and safety are maintained in all aspects of cryo-TEM sample preparation, imaging, and data analysis. NIS is a leading provider of GMP-compliant cryo-TEM imaging and analysis, offering comprehensive solutions for your biopharmaceutical development and manufacturing needs.
How can you benefit from GMP compliant nanoparticle characterization services?
- Gain comprehensive and robust characterization of your in-process or finished pharmaceutical or drug formulations with cutting edge technology.
- Submit quality objective evidence in regulatory filings with support from experienced scientists.
- Ensure reproducibility, reliability, and traceability of data for regulatory submissions.
- Receive expert guidance in every step of your drug discovery workflow from R&D to scale-up and batch-to-batch comparisons.
Submit filings confidently with NIS’s cGMP compliant nanoparticle characterization services.
NIS is the first and only GMP-compliant cryo-TEM laboratory in North America and is committed to delivering exceptional quality imaging while adhering to Good Manufacturing Practice (GMP) regulations.
Our Quality Unit has implemented a quality system compliant with 21 CFR 210-211 and established reliable, repeatable, and reproducible cryo-TEM nanoparticle characterization processes. From imaging to qualitative analyses, including fraction counting and particle size distribution determination, our processes are in-depth and documented, in order to provide you with objective evidence.
We are dedicated to providing you with the highest-quality cryo-TEM/TEM imaging services, allowing you to make critical decisions confidently during your drug development journey. Our GMP compliant cryo-TEM and TEM services align with industry regulations, ensuring your success in today’s highly regulated environment.
Reach out today to learn how we can help you.
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