nir-vana innovation network

The middle-sized company has three divisions with its headquarters in the German southwest region of Rhineland-Palatinate. With 150 employers it is looking back on 30 years of experience. The company has an understanding of the entire value chain of a pharmaceutical product and can provide support with its services at every stage, therefore can offer expertise for all companies in the pharma and biotech sector, even young enterprises, which have special limits in terms of financial expenditure and therefore have very special requirements for implementation according to plan. A comprehensive service portfolio is offered, ranging from drug development, analytical services and quality control, manufacturing of clinical batches and small market batches to pre-clinical development, pharmacovigilance and GxP services. Critical points are identified right from the start and, if necessary, the work packages are processed according to plan by involving experts from the business network. Together with network partners, the company also supports clinical and pre-clinical studies. The offer extends equally for small and large molecules, in which customers can take advantage of a special experience and expertise in the field of drug development. The formulation development covers a broad range of dosage forms, e.g. liquid, semi-solid and solid for parenteral, oral or nasal applications. Drug development / Technology platform: The vast majority of new chemical and biological active pharmaceutical ingredients (“APIs”) are poorly soluble in water and physiological media. These active ingredients are difficult for the body to take up and are therefore poorly available at their target site in the body. The company has established an innovative screening and technology platform for the fast, flexible and cost-effective development and manufacturing of parenteral (sterile) and nasal drug formulations with poorly soluble APIs. Micro- and nanotechnology are important components of the technology platform to improve the bioavailability of poorly soluble active ingredients. The technology platform for parenteral, nasal and oral applications focuses on the development of innovative and affordable drugs with a special focus on poorly soluble small and large molecules.This project was supported by funding from the European Regional Development Fund (ERDF). Pharmacovigilance: Pharmacovigilance services are comprised of automated literature search and assessment, AI supported vigilance processes, EU-QPPV, Graduated Plan officer acc. to German drug law, information officer. Laboratory services : A full standard service, e.g. method development and validation, purity testing including structure elucidation, release, stability and stress testing is completed by latest test methods and state-of-the-art equipment “Qualified Person” QP services: A QM officer and wholesale representative is provided and supports the customer to fulfil the legal obligations, which include batch release, GxP services and audits, application for manufacturing, import and wholesale authorisation, implementation and maintenance quality assurance systems, batch certification and release with QP certification.