Bridging your regulatory needs to pharma solutions

  • Regulatory affairs

    For companies in the healthcare and pharmaceutical sector
  • Pharmacovigilance

    Monitoring of your products’ safety profile as well as medical literature for identifying potential adverse reactions
  • Information

    Timely information on all new requirements and updates in medicinal products legislation and pharmacovigilance amendments
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Pharma Support Services

As a specialized service provider Pharma Support Services is created to find answers to your regulatory queries and help your pharma business achieve compliance with the local requirements on the Bulgarian and Romanian markets. Taking care of all aspects from dossier evaluation through regulatory approval to post authorisation support we are ready to provide our expert advice at every step you need it. Once on the market you take care of selling your product, we take care of its regulatory compliance and safety concerns.

What we offer

Regulatory affairs services

Regulatory strategy and consultation

Be it a national or an international procedure we can support your application in its national phase or as national authorisation procedure. Our expertise is based on years of experience with Bulgarian and Romanian agencies so we are confident we can meet your needs. Depending on your product we can outline the right regulatory path and point out any possible pitfalls or deficiencies in your dossier. Project management also involves preparation of the necessary documentation for submission and handling day-to-day communications with the authorities. Once submitted we follow-up your application and supervise the whole authorisation process until its successful outcome.

Local Support in MRP and DCP

From submission of regulatory documentation through validation and timely follow-up we provide local support in MRP and DCP procedures for Bulgaria and Romania. Essential part of this kind of support is preparation of accurate translations and follow-up with the agency. Once submitted we take care of your application until its marketing authorisation is granted.

Lifecycle management and post authorisation services:

Following successful authorisation your product needs to be maintained via variations and renewed as set out in the drug legislation of the respective countries we operate in. We can support you with all services related to variations, MA transfer applications, renewal procedures etc. We keep track of your deadlines so your product is always compliant and its smooth market presence is not interrupted by regulatory hurdles.

Ad hoc regulatory affairs services:

For any transitional period due to shortage of staff, prolonged illness, maternity leave or other you might need temporary regulatory expertise. Ranging from preparation and submissions of documents to ad hoc part-time on-site work we can support your regulatory department if you suffer from temporary lack of resources. Please contact us for further communication on this service.