Nanomol Technologies works with the highest quality standards in compliance with the Good Manufacturing Practices (GMP). Nanomol Technologies has been a contract analysis laboratory for API manufacturers for more than 7 years. Our clients trust the excellence of our particle characterization services. We have been qualified, and successfully requalified, by customers and external auditors. We are eager to obtain the GMP certificate by the Spanish Agency (AEMPS) to become an internally recognised contract laboratory for particle analysis of finished and intermediate pharmaceuticals for investigational, human and veterinary medicinal products.
We fully adapt to our customer needs, are versatile and highly flexible regarding the products analysed (from excipients to highly active, from API to final dosage forms) and apply the pharmacopoeial and ISO standards in particle analysis, method development and validation (USP429, Ph.Eur. 2.9.31, Ph.Eur. 2.9.48, ISO13320:2020 and ISO 22412:2017).
In Nanomol Technologies contract analysis unit, we assure:
- The qualification of our equipment, facilities, utilities and systems.
- The validation of our methods for release.
- Highly qualified personnel (>20% PhD; >75% MSc) under a continuing training program
- Compliance to Good documentation practices and Data integrity principles
- Investigation of Out of specification results
- Quality Risk Management
- Digital transformation: eQMS
The staff of our laboratory is highly qualified to work in compliance with GMP standards to guarantee fully reliable and traceable results from robust analytical methodologies. The Quality Assurance Department maintains and improves the quality system concerning the whole analysis process, from the reception of the samples to report delivery and waste management.