Regulate B.V.

Over Regulate B.V.

CH-Regulate B.V provides a “one stop medical device product development service” from product conceptualization, design & development, all cellular, molecular, mechanical, histological, drug/growth factor coating and release profile analysis, prototype development, validation, technology transfer, and GMP manufacturing under ISO:13485 regulations for CE/FDA approval by a team of experts with 30+ years of experience in the field. In specific, the team has in-depth expertise in dental, orthopedic, wound care, bone graft substitutes -derived from xenografts, allografts, bioactive ceramics, calcium phosphates and composites.

CH-Regulate B.V offers:

Biochemical / Molecular/Cell Biology assays -Total DNA assay -Alkaline Phosphatase Assay -Total Calcium assay -ELISA, PCR, Flow Cytometry -Antibiotic, Growth Factor coating and release assay

Histology and Microscopy -Hard and soft tissue processing -Paraffin, MMA /GMA embedding, staining and microscopy -Image analysis and reporting -Immuno-staining of soft and hard material such as bone, enamel, metals, polymers, ceramics

Mechanical Property testing of Medical Devices -Physico-Chemical Characterization of materials -HPLC, EDX, EM, XRD and FTIR -Mechanical characterization of materials: Tensile strength, Rheology etc.

Prototype –to production with regulatory, CE/FDA road map: -OEM Production of Medical Devices Pharmaceuticals; and human Tissues and Xenograft products -Batch production for clinical studies or product registration under GMP Conditions -Test method development and production process validation, Product registration, Quality control for manufacturing and related assistance.

The Team: Dr. Frank Walboomers Ms. Henriette Valster Mr. Christian van Munster Dr. Ram Siddappa Mr. Koen Dijkstra

Adres

• Hoofdkantoor

  Kerkenbos 10-1136546BJ NijmegenGelderland, Nederland

Team per functiegebied

Gebaseerd op 1 openbare functieprofielen, stand van 2 september 2026.

• Sales1