Regulatory Affairs Services

Sveikuva provides regulatory affairs services for medicines, medical devices, food supplements and cosmetics since 2004. Scope of our regulatory activities covers early product lifecycle steps and includes from technical, pharmaceutical and medical writings to global regulatory project coordination.
Sveikuva has developed quality assurance system, including standardised working procedures and processes, which allows assure regulatory affairs services compliance.
Work organisation gives possibility to provide client with clear and convenient contact point, assure fast submission of procedures and involved back-ups.
We are locally operating in following countries: Baltics (Estonia, Latvia and Lithuania), Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia and in some other EU countries.

We provide following services:

  • Obtaining marketing authorisation of medicines (national procedure, DCP/MRP, centralised procedure)
  • Maintenance procedures (renewals, variations type IA, IB and II, other changes: Article 61(3), classification of supply
  • Registration & notification of medical devices
  • Registration & notification of food supplements and foods for special medical purposes
  • Notification of cosmetic product

Additional services :

  • Technical, Pharmaceutical and Medical writings:
    • RMPs, PSURs
    • Quality, Clinical and Non-clinical Overviews and Summaries
    • Other Dossier documents
  • Regulatory and Medical review of marketing materials
  • Price declaration and reimbursement applications

Regulatory Affairs Services

Sveikuva provides regulatory affairs services for medicines, medical devices, food supplements and cosmetics since 2004. Scope of our regulatory activities covers early product lifecycle steps and includes from technical, pharmaceutical and medical writings to global regulatory project coordination.
Sveikuva has developed quality assurance system, including standardised working procedures and processes, which allows assure regulatory affairs services compliance.
Work organisation gives possibility to provide client with clear and convenient contact point, assure fast submission of procedures and involved back-ups.
We are locally operating in following countries: Baltics (Estonia, Latvia and Lithuania), Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia and in some other EU countries.

We provide following services:

  • Obtaining marketing authorisation of medicines (national procedure, DCP/MRP, centralised procedure)
  • Maintenance procedures (renewals, variations type IA, IB and II, other changes: Article 61(3), classification of supply
  • Registration & notification of medical devices
  • Registration & notification of food supplements and foods for special medical purposes
  • Notification of cosmetic product

Additional services :

  • Technical, Pharmaceutical and Medical writings:
    • RMPs, PSURs
    • Quality, Clinical and Non-clinical Overviews and Summaries
    • Other Dossier documents
  • Regulatory and Medical review of marketing materials
  • Price declaration and reimbursement applications