As a result of the BREXIT, the pharmaceutical industry should be proactive in preparing for BREXIT related regulatory changes.
Marketing Authorization Holders (MAHs) and applicants of centrally authorized products or products authorized via MRP/DCP need to ensure that all necessary changes have been fully completed and implemented by 30 March 2019.
The experienced regulatory affairs experts of STARoDub B.V. are ready to support pharmaceutical companies manufacturing small molecules, biotechnological/biological products and/or orphan drugs in all regulatory activities required as a result of this transition.
STARoDub B.V. can assist you in performing a risk assessment to identify the required regulatory and quality activities and can support you with e.g.:
- Transfer of marketing authorization to a holder established in the EU (or EEA)
- Change of Reference Member State (RMS) if the current RMS for your authorized product is UK
- Transfer of orphan designation to a holder in the EU (or EEA)
- Submission of variation to add an importer for the medicinal product into the EU
- Submission of variation to change the site of batch control and/or batch release
- QP services
STARoDub B.V. is able to support you to prepare your documentation in eCTD format and support the submission.
Furthermore, STARoDub B.V. is registered as SME (Small and Medium Enterprises) company at EMA. Therefore, companies can indirectly benefit from the SME incentives through STARoDub B.V. as SME regulatory consultancy.
Be prepared and let STARoDub B.V. support you to take the necessary steps to enable undisrupted supply of your medicinal products for the benefit of the patients!
Please contact us for more information: firstname.lastname@example.org