nuvalore GmbH

As a contract quality control laboratory based in southwestern Germany, nuvalore GmbH specializes in the analytical characterization of pharmaceuticals and biopharmaceuticals. In the short time since its founding, the company has already developed a reputation for excellence in developing robust analytical methods and delivering high-quality analytical, validation, and quality assurance solutions to its clients in the pharmaceutical and life sciences industries.

Additionally, it provides consultancy services in the areas of Quality by Design (QbD), Analytical Quality by Design (AQbD), Design of Experiments (DoE) methodologies and GMP Compliance.

At the core of nuvalore’s operations is a commitment to excellence in quality management and providing customized solutions with analytic results that meet the highest regulatory standards. Beyond traditional laboratory analysis, nuvalore fosters partnerships based on trust, innovation, and exceptional customer service, contributing to advancement and innovation within the demanding field of life sciences.

Vision and Mission

Nuvalore derives its name from the Italian words “nuovo” and “valore,” signifying “new value.” The nuvalore vision is the creation of seamless links between science and quality, ensuring world-class laboratory services through a fresh and innovative approach, utilizing cutting-edge technologies and proven methodologies to transforming scientific projects into drug products that meet the highest quality and safety standards for patients.

The company’s mission is to act as a trusted partner in the pharmaceutical and life sciences industries, employing innovative approaches and cutting-edge technologies to offer reliable and accurate services tailored to the specific needs of its clients, becoming a strategic link in their journeys towards success. The company is not merely a laboratory service provider; it is a collaborator equipped with the right tools to expedite the market entry of client projects.

Activities and Products

Nuvalore offers three main types of service:

• Analytical Quality by Design (AQbD): Implementing AQbD approaches to develop robust analytical methods in agreement with ICH Q14 guidelines.
• Method Development, Validation, and Transfer: Utilizing Design of Experiments (DoE) to develop and validate methods, focusing on quality control methods for stability testing of parenteral and oral medicinal products.
• Product Characterization: Providing a wide range of analytical methods, including routine compendial quality control analyses according to Eur.Ph. and USP, identification and characterization methods, protein characterization, characterization of surfactants, testing of primary packaging materials, and application systems.

Within these broad service streams, the comprehensive nuvalore service portfolio includes:

• Product optimization and development of analytical methods using QbD and design of experiments (DoE)
• Method development, validation and transfer
• Consultancy
• Characterization of drugs and routine analysis:
  • Pharmacopoeia Methodologies
  • Peptide-Mapping (PepMap)
  • Cation Exchange HPLC (CEX)
  • Hydrophobic Interaction Chromatography (HIC)
  • Hydrophilic Interaction Liquid Chromatography (HLIC)
  • Capillary Isoelectric Focusing (cIEF)
  • Capillary Electrophoresis (CE)
  • Characterization of surfactants (e.g. PS80, PS20, Pxm188)
  • Enzyme-Linked Immunosorbent Assays (ELISA)
  • Force Measurement of Prefilled Syringes and Autoinjectors (e.g. Break -loose Force, Glide Force)
  • Dissolution-Testing
  • Measurements of nanoparticles

Company History and Structure

Founded in January 2024, nuvalore GmbH is a privately held company registered in Mannheim, Germany and operating from its headquarters in Leimen, Baden-Württemberg. Founder and CEO Dr. Anamarija Ćurić is a scientist with extensive professional experience in the pharmaceutical industry, specializing in drug product development. Other members of the management team include Verena Lenz managing Laboratory Facilities and Analytical Method Development. They work alongside a team of scientists with long professional experience in industry and deep knowledge of regulatory requirements.

Within its first year of operations, the company had set up a fully equipped laboratory, established a QMS quality management system and undertaken full CSV computer system validation to meet cGMP standards, completed several feasibility studies for pharma clients, and was on course to seek full GMP certification.

Nuvalore has established a strong advisory board and has become a is a member of BioRN, the innovation cluster for science and industry in the Rhine-Neckar region, and Pharma Deutschland, the largest pharmaceutical industry association in Germany.

Quality, Regulatory & Standards

Nuvalore places a strong emphasis on quality management to ensure that the results of its analyses meet the highest standards. Its internal QMS is in accordance with EU 2017/1572 standards to include fully qualified facilities and personnel.

The company operates in accordance with regulatory standards, including ICH and EU-GMP guidelines, to ensure full compliance with Good Manufacturing Practice (GMP) regulations. Data integrity is a top priority, with raw data and reports handled securely in fully validated computer systems.