Our Services

Combisolve is specialized in regulatory compliance and quality assurance for combination products. Our focus is on the medical device component, including the medical device interrelations between the biologic, drug and medical device in the combination product, and concerns the US combination products regulatory compliance requirements.


Our regulatory compliance and quality assurance services for combination products and for medical devices are:

  • Regulatory Compliance
  • Clinical Evaluation
  • Global Registration
  • Quality Assurance
  • Training
  • Auditing


Combisolve represents service providers who deliver these services. Our main partners are:

A global leading medical device consultancy group

An international business development, interim management and consultancy company.