Certificates

To deliver high-quality solutions to our clients, we adhere to high standards for the development and manufacturing of your medicines:

AAALAC

AAALAC

The AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation demonstrates a commitment to responsible animal care and use. The accreditation is widely recognized as a benchmark for excellence in animal welfare.

biocrates

biocrates

Our laboratory team has been trained and certified by biocrates to use the kit and provide metabolomics services to customers.

BSFZ

NUVISAN has received its official recognition with the BSFZ Seal from the “Bescheinigungsstelle Forschungszulage” (Certification Authority for Research Allowance). The BSFZ Seal, a vital government funding measure, marks a milestone, underscoring our ongoing pursuit of research excellence. This honor celebrates our commitment to innovative research, confirming our competence and dedication to driving innovation.

BSL-2 Laboratory Practices

NUVISAN features state-of-the-art biosafety level 2 (BSL2) facilities dedicated to handling wildtype viruses and bacteria as well as viral vector systems.

cybervadis

NUVISAN has achieved a CyberVadis score of 856/1000, showcasing our dedication to Data Privacy, GDPR, Data Protection, Third Party Management, and Business Continuity. CyberVadis ensures a high standard of cybersecurity, reinforcing our commitment to a safe environment for drug discovery and development projects in the new year.

ecovadis

A certification proving our high level of performance in areas such as environmental stewardship, labor practices, ethics, and supply chain management.

French Research Tax Credit (CIR) Accreditation

A tax incentive program in France that is designed to encourage research and development (R&D) activities by companies.

GCP

GCP

Good Clinical Practices (GCP) is a set of internationally accepted ethical and scientific quality standards for the design, conduct, monitoring, and reporting of clinical trials. GCP guidelines are intended to protect the rights, safety, and well-being of study participants, and to ensure the validity and reliability of the data generated from the trial.

We follow the ICH GCP Guidelines, the Clinical Trial Regulation (EU) No 536/2014 and other relevant guidelines and are GCP certified by ANVISA.

GDP

GDP

Good Distribution Practices (GDP) refer to the guidelines intended to ensure that medicinal products are stored, transported, and handled correctly, so that their quality and safety are maintained throughout the supply chain.

We follow the EU guidelines on Good Distribution Practice of Medicinal products for Human use in connection with the handling of clinical trial supplies.

GLP

GLP

Good Laboratory Practices (GLP) are a set of guidelines and regulations that are intended to ensure the integrity and reliability of non-clinical safety studies. These studies are typically conducted on pharmaceutical products, pesticide products, cosmetic products, veterinary drugs, as well as food additives, feed additives and industrial chemicals. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.

We follow the GLP OECD guidelines, national guidelines like the German “Chemikaliengesetz” and Directive 2004/9/EC and are GLP certified by the national competent authorities.

GMP

GMP

Good Manufacturing Practices (GMP) are a set of guidelines and regulations that are intended to ensure the quality and consistency of drugs products for human or veterinary use throughout the manufacturing, testing and release process.

We follow the EU GMP and US FDA cGMP guidelines an are GMP certified by the national competent authorities.

Our sites are GDUFA registered an thus allowed to perform testing on drug substances and drug products satisfying the good manufacturing practices testing requirements.

10x Genomics

A "Certified Service Provider" (CSP) for their single cell sequencing technology is a company or laboratory that has been trained and certified by 10x Genomics to use their technology and provide sequencing services to customers. These providers have demonstrated a high level of technical expertise and are able to generate high-quality data using 10x Genomics' single cell sequencing products.