Regulatory affairs services include: (click on link for more information)
• Strategic regulatory advice
The optimal strategy to register a medicinal product in Europe requires consideration of issues such as which procedure to use (centralised, mutual recognition or decentralised), whether to obtain scientific and/or pre-submission advice, whether it is opportune to request Orphan Drug status, and the selection of a Reference Member State or preferred Rapporteur. Dorian Regulatory Affairs can advise you regarding these strategic decision points that will significantly impact on your application.• Marketing authorisation applications
Dorian Regulatory Affairs can handle the preparation and compilation of a European dossier in (e)CTD-format on your behalf, including follow-up until registration. We will liaise with the EMA and national authorities on your behalf. Services include preparation and review of documentation, arranging the necessary translations, the national country specific documents, payment instructions etc. For eCTD preparation and publishing, we cooperate with a company specialised in eCTD publishing.
Alternatively, we can act as an additional pair of hands to assist you with a particular task.
Sooner or later, all registrations require variations and/or line extensions to keep up with the scientific and regulatory developments and to maintain an efficient manufacturing process. These applications can be prepared and submitted on your behalf, both nationally and EU-wide, including follow-up until approval.• Liaison with regulatory authorities
Over the years, Dorian Regulatory Affairs has established good contacts with the various EU authorities, including the EMA. We will liaise with the various authorities on your behalf, and act as the official EU contact point for your procedure if necessary. If your company is not established in the EU, we can also act as sponsor for your application.• Orphan drug designation
Dorian Regulatory Affairs has handled many Orphan drug designation applications and can advise whether your drug potentially qualifies for EU Orphan drug status. We can prepare the orphan drug application, arrange pre-submission meetings and follow-up until closure of the procedure on your behalf. As the applicant needs to be established in the EEA, Dorian Regulatory Affairs can act as sponsor for non-EU companies without an EEA affiliate, until a company presence in the EEA is established.• Small and medium-sized enterprise status (SME)
The EMA offers small and medium enterprises the possibility to obtain SME status. SME status is associated with various advantages, ranging from financial incentives to procedural assistance. It is a requirement that the company is established in the EEA. Dorian Regulatory Affairs can help you arrange SME status. For companies located outside the EEA, Dorian Regulatory Affairs offers the opportunity to obtain SME status through Dorian's SME status.• Evaluation for in-licensing purposes
Evaluation of the chemical-pharmaceutical, pre-clinical and clinical part of the dossier for compliance with regulations and guidelines is an important step in determining whether a product offered by another company offers a business opportunity. Knowledge of the guidelines and practical experience with regulatory requirements are critically important for making the right judgement.• Regulatory intelligence services
Keeping up to date with the EU legislation and guidelines in the area of the registration of human medicinal products is a core activity of Dorian Regulatory Affairs. We provide various types of regulatory intelligence services, varying from addressing a specific enquiry, to keeping you informed regarding a specific topic or area of development, to writing manuals or white papers.• Product information
All marketing authorisation applications in the EU need to be accompanied by proposals for a SPC, label and patient leaflet, in accordance with the available guidance notes. Dorian Regulatory Affairs can prepare these texts in English and Dutch, and arrange the necessary translations in the other EU languages. Readability testing can be arranged through a company specialised in these services.• Scientific advice/protocol assistance
Despite the growing number of guidelines and notes for guidance, it is generally a challenge to determine the best R&D package to achieve an expeditious and commercially attractive registration. Generally, companies are advised to avail themselves of the advice services offered by the EMA and national authorities. Dorian Regulatory Affairs can prepare the submission package and arrange and participate in these meetings on your behalf.• Paediatric investigation plans (PIP
The paediatric regulation, which came into force on 26 January 2007, requires all new product applications to include a paediatric investigation plan (PIP) for the development of the product in children. If the product is for conditions that do not affect children, or would be ineffective or unsafe in children, the sponsor can request a waiver from the requirement. In addition, there are compounds for which it can be justified to first complete development in adults before investigating in children, and hence request a deferral. Dorian Regulatory Affairs can assist with ensuring compliance with the paediatric regulation.• Related services
Regulatory affairs is at the crossroad of various disciplines, all needed to meet the goal of a successful registration procedure. Dorian Regulatory Affairs has established a network with colleague consultants in Europe and the US, specialists in their own areas, to assist if necessary. Amongst others, this includes toxicology, medical writing, pharmacovigilance, eCTD publishing, pricing & reimbursement and GMP. In addition, contacts with national regulatory consultants in the various EU countries, Switzerland and the US are in place for specific national advice if necessary.
For specific questions and/or more details, please contact us.