Services for Lifescience and healthcare industry

The Life Sciences and Healthcare Industry is one of the most regulated industries. It is becoming more dependent on digital technologies to provide efficient clinical treatments, improve diagnoses, develop new products and enhance health services to meet the expectations of patients around the globe. Companies are struggling to keep up the speed of innovation without compromising their regulatory integrity. Deloitte can help you implement solutions by using a data-driven and risk-based approach to regulatory compliance that focuses on enabling business, instead of restricting it with additional procedures and rules.

Our Services

I. Digital therapeutics and Software as Medical Device (SaMD)

  • Classification of Digital therapeutics and SaMD
  • Pre & post marketing activities
  • Clinical validation
  • Commercialization and Market Access
  • Quality Management System (QMS)
  • DiGA listing

II. Regulatory Affairs 

  • Pre & post marketing activities
  • Drug development plans
  • Regulatory strategy
  • Regulatory in Clinical trials
  • Due diligence
  • Commercialization and Market Access

III. Quality Management Systems

  • Implementation of Quality Management System (QMS)
  • Implementation of various digital systems for quality management in R&D and Clinical trials (Veeva, Flex etc.)
  • Implementation of Regulatory Information Management systems (RIM)

IV. Pharmacovigilance

  • Implementation of vigilance system for drugs
  • Pharmacovigilance system optimization and validation
  • Audit

Contact us

Martin Kubačka

Martin Kubačka


Martin is a Partner in the Risk Advisory department of Deloitte in the Czech Republic. He leads the Operational Risk offerings, including data privacy, regulatory compliance, GRC, extended enterprise ... More

Pavel Nevický

Pavel Nevický


Pavel has 20 years of professional experience. He worked on various life-science positions, founded a digital therapeutics company focused on severe mental disorders, worked on the market access strat... More