Specialty Diagnostic (assay) kits

Specialty Diagnostic (assay) Kits are a key component of our Clinical Trial Services & Logistics Excellence (CTSL) portfolio. It operates as an ISO 13485:2016-certified production laboratory specializing in molecular and immunodiagnostic assays.

We provide contract-manufacturing services for specialized diagnostic products across various technology platforms, including Real-Time PCR. Our products are available as CE-marked In Vitro Diagnostics (IVDs) or Research Use Only (RUO) kits, and we frequently serve as OEM manufacturers for Life Science companies.

Our HPV detection and typing kits are distributed globally, supporting vaccine and epidemiological studies, as highlighted in the HPV SPF10 brochure.

Contract manufacturing capabilities:

• Production Services CTSL provides services for the development, validation, and/or production of molecular test kits
• Production and aliquoting of buffer solutions in various vials and volumes
• Professional kit labeling facility. Kit label design in compliance with IVDR
• A wide range of packaging solutions
• Generation of kit inserts, Safety Data Sheets, and instruction leaflets
• Full kit assembly
• Generation of QA documentation required for CE-IVDR compliance
• Production of sampling kits for use in clinical trials and diagnostic testing
• Worldwide distribution and collection

Quality Assurance

At Cerba Research, Quality Assurance is paramount. Lloyd’s Register Quality Assurance (LRQA) has certified our kit production facility according to the international quality standard ISO 13485:2016. We are proficient in production in compliance with the IVDR directive (EU) 2017/746 and FDA Regulations.

In addition to the official quality standards, Production Services CTSL can accommodate additional tailor-made quality requirements upon request, including the full spectrum of logistic and production activities. Our employees are continuously trained in applying quality assurance principles throughout our organization.