Regulatory strategy and consultation

We can coin your regulatory strategy depending on your need and expectation from the market. Whether national or an international procedure we can support your application in its national phase or as purely national authorisation procedure. Our expertise is based on years of experience with Bulgarian and Romanian authorities so we are confident we can meet your needs. Depending on your therapeutic focus and portfolio we can outline the right regulatory path and point out any possible pitfalls or deficiencies in your dossier. Our 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 throughout 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 authorities. 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 reasons 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 are challenged by temporary lack of resources. Please contact us for further discussion on this service.