Regulatory Affairs

Atran can provide support in regulatory strategies to make sure the best way for shorten time to market with a high quality and comply with the available guidelines. This can be both in product development and during life cycle management. We have supported the pharmaceutical industry with regulatory expertise for many years.

Your regulatory partner

 

With our extensive experience within Regulatory Affairs we can provide you with the procedural guidance (CP, MRP, DCP, national etc) to make sure the best path for your product to reach the Marketing Authorisation depending on aspects such as time to market, cost effectiveness and preferred markets.

The Marketing Authorisation is not the end, but of course a crucial milestone for your product and your company. At this point the life cycle management starts, which can be seen as its own speciality. Every change you want or need to make to your product, from formulation changes, new indications,  changes to packages or inserts, addition or replacement of manufacturing sites etc, may require a regulatory variation.

The Atran team specialises in this part of the post approval product development to make sure that your product can reach its potential when treating patients and generating revenue. From the registration process to product launch through management of every regulatory variation we are there as your regulatory partner.

Our Services include

  • Marketing Authorisations

  • Variations, Renewals

  • eCTD support

  • CMC writing

  • Due diligence (dossier audits)

  • Market access

  • Product information services

  • Promotional material