Product Expertise
Understanding the science behind your product
Orphan drugs, biologics, or implantable devices present completely different challenges.
Our work is led by product specialists, experienced in bringing to the market the type of
product that our clients are developing.
Drug-device combination products associate a drug with a medical device, and hence bridge different regulatory frameworks (drug or device). Drug-device combinations can be single products comprised of several components – e.g. transdermal patches, drug-eluting stents – separate products packaged together – e.g. syrup with spoon – or products packaged separately but intended for use only with a specific counterpart – e.g. antitumor drug to be injected with a specific needle to target the tumor in the relevant organ, or insulin pumps designed only for specific insulin formulations. Read More

VCLS Solutions

Science-based, global product development strategy and planning

  • Advise on product qualification and classification as well as product registration path
  • Assist with claims positioning
  • Advise on combination product co-development plan
  • Prepare for/conduct international regulatory bodies Innovation Meetings (Notified Bodies, EMA, FDA)
  • Develop roadmaps towards international regulatory approvals (EU, US, Australasia, South America)
  • Assist with preclinical and clinical development plans
Tactical operations

  • Interact with international regulatory bodies (Notified Bodies, EMA, FDA,)
  • Develop risk analysis and risk management plan
  • Submit international Clinical Trial Application
  • Build/support implementation Quality management system and Good Manufacturing Practices (GMPs)
  • Prepare product international regulatory dossiers (in Europe: CE mark Technical File; FDA: RfD (request for Designation), 510k, PMA; Canada; Australasia; South America)
  • Build/support implementation vigilance system
  • Assist with Post-marketing surveillance (PMS)
  • Advise on labeling and advertising