We want you to always be informed of everything we are doing, new projects, our future challenges and our milestones.
ACHIEVEMENT: GMP CERTIFICATION
We are especially excited to share with you that DEKAPENTA LABS has just received from the Spanish Agency for Medicines and Health Products (AEMPS) authorization to open a new physical-chemical quality control laboratory, including said control for imported products. Likewise, the corresponding certificate of compliance with the «European Union Good Manufacturing Standards (GMP)» has been received.
ACQUISITION OF A MS
We have just acquired and installed new mass spectrometer (MS) in our Laboratory. Specifically, a triple quadrupole MS spectrometer coupled to a UPLC (UPLC-MS/MS).
With this new instrument, DEKAPENTA LABS is able to develop and carry out analyses of Nitrosamines and Genotoxic Impurities, in addition to being up to date with new market needs.
This instrument is capable of detecting traces at ppbs levels, allowing us to reach increasingly lower limits in an exact and precise way.
We have already started the procedures to obtain the authorization of the GMPs.
All the work we’ve been doing these months is finally coming to an official step. The technical report has already been submitted to the Spanish Medicine Agency and we are waiting for the audit.
We look forward to offering you our services under the GMP certification soon.
However, we are active in performing analysis that do not require such certification such as method development, validations, transfers, or ICH stabilities.
WE ARE OPENING
We open the doors of our Laboratory.
After months of work, we can already say that Dekapenta Labs is a reality. We have arrived with desire and energy to open our doors to you and offer you our best services as a CRO of Physicochemical Analysis.
We are currently processing the visit of the Spanish Medicine Agency, so that we can be authorized with GMP’s Certification.
In the meantime, however, we can perform all those services that may be excluded from this Certification.
So we hope to see you soon and that from now on Dekapenta Labs, can be a reference for you.