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 services 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 to assure compliance of regulatory affairs services.

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 Baltics (Estonia, Latvia and Lithuania) and following countries:, Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia and in some other EU countries.

We provide the following services:

  • Obtaining marketing authorisation of medicinal products (national procedure, DCP/MRP, RUP, centralised procedure)
  • Obtaining parallel import/distribution marketing authorisation of medicinal products (national procedure, centralised procedure)
  • Post-authorisation procedures (renewals, type IA, IB and II variations, other changes: Article 61(3), changes in classification of supply, products line extensions, management of Sunset Clause).
  • Registration & notification of medical devices
  • Registration & notification of food supplements and foods for special medical purposes
  • Notification of cosmetic products

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 Promotional 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 services 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 to assure compliance of regulatory affairs services.

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 Baltics (Estonia, Latvia and Lithuania) and following countries:, Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia and in some other EU countries.

We provide the following services:

  • Obtaining marketing authorisation of medicinal products (national procedure, DCP/MRP, RUP, centralised procedure)
  • Obtaining parallel import/distribution marketing authorisation of medicinal products (national procedure, centralised procedure)
  • Post-authorisation procedures (renewals, type IA, IB and II variations, other changes: Article 61(3), changes in classification of supply, products line extensions, management of Sunset Clause).
  • Registration & notification of medical devices
  • Registration & notification of food supplements and foods for special medical purposes
  • Notification of cosmetic products

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 Promotional Materials
  • Price Declaration and Reimbursement applications