Medicinal products

From assistance in simple regulatory tasks to ensuring full regulatory compliance.

From assistance with performing regulatory activities to outsourcing. Outsourcing is a key strategy that enables you to focus on your competitiveness.

Regulatory support prior to obtaining marketing authorisation

  • Documentation compliance checks
  • Licensing support
  • Optimisation of regulatory procedures
  • Effective communication with competent authorities and industry
  • Responding to regulatory authorities′ questions
  • Expert opinions, overviews (pre-clinical, clinical) and dossier preparation and submission
  • Assisting in GMP compliance

Life-cycle management regulatory support

  • Regulatory tasks necessary for maintaining marketing authorisations (variations and renewals)
  • SmPC/PIL services (QRD compliance, translations, artwork…)
  • Advertising review and compliance
  • Pharmacovigilance and safety issues

Contact us for more information on further services and find out how we can tailor these to you.

Medical devices

We offer regulatory assistance to medical devices manufacturers, wholesalers and retailers / specialised shops. We can help with complicated regulatory compliance and outsourcing.

Professional regulatory support

  • May be decisive in borderline and classification issues
  • Before acquiring CE mark, helps you get to market faster
  • After acquiring CE mark, makes post-marketing surveillance easier, especially vigilance issues

Professional regulatory support we provide

  • Classification of products as medical devices
  • Product description
  • Medical device classification (class I, IIa, IIb, III)
  • Optimal choice of Conformity Assessment Procedure
  • Product development
  • Compliance with general safety and performance requirements (essential requirements)
  • Preparation of technical documentation
  • EC certification procedure and Declaration of Conformity
  • Labelling and Instruction for Use services
  • Risk assessment, risk management
  • Vigilance and safety issues
  • Registration support (activity, medical devices) with competent authority

We will help you develop standard operating procedures (SOPs) linked to your activities: including post-marketing surveillance, development and maintenance of vigilance systems for medical devices.

Contact us for more information on further services and find out how we can tailor these to you.

Food supplements

Assisting you in achieving regulatory excellence in the food supplement sector.

We offer regulatory assistance to food supplement manufacturers, importers and wholesalers. Let us assist you with all the complicated regulatory compliance and outsourcing.

Professional regulatory support we provide

  • Classification of products as food supplements
  • Compliance and composition review before marketing in Slovenia
  • Regulatory compliance
  • Labelling compliance review and preparation
  • Nutrition and health claims reviews
  • Compliance with Good Hygiene Practices and general requirements for food premises, education, traceability, recall etc.
  • Inspection assistance

Contact us for more information on our services and find out how we can make these work for you.