Do you have access to clinical and toxicological experts?
Yes, we have built up good working relationships with the type of experts required for supporting regulatory submissions. These specialists are based in many different countries and we can usually match up your therapeutic area to an appropriate expert who has relevant experience of generating reports for regulatory review. We can manage this interaction for you so that your objectives are met with a minimum of fuss. This support can be flexed in and out as the demands of the project dictate.
Can you work with our team on site?
Yes, we provide both on-site and off-site assistance for projects, according to your needs. We often find it helpful to spend some time on site at the beginning of each project to meet the relevant people and to understand your company processes. Usually work can then be completed on an on- and off-site basis, to minimise disruption to your day-to-day work. Our IT systems allow us the capability to access client systems where a VPN exists.
Do you have access to individual country knowledge?
Yes, we are part of a network of independent regulatory consultants throughout Europe and also have access to local expertise in the US and other significant territories. This allows us to offer the most up to date local knowledge regarding legislation and Competent Authority interaction. We will manage this process so that you can have one point of contact for all relevant countries.
What Languages do you work with?
English is the primary language required by our clients and is the primary common language for submission to EU authorities. However, the Real Regulatory team supports both English and French submissions, and the extended Real Regulatory network of consultants, provide support in all relevant languages in Europe.
Can you provide temporary cover?
Yes, we have experience of providing both on-site and off-site temporary cover where additional resource is required. For example, in the preparation of regulatory submissions and responses to authorities; pre-audit preparation; holiday, sick cover and maternity leave.
Can you assist us by managing our project with input from our team?
Yes, we have experience of managing short and long term projects where a client has some but not all of the required experience in-house. Our skills can supplement the skills of the client team as necessary and can be flexed in and out as the demands of the project dictate.
Can you provide us with training specific to our company?
Yes, if you have a specific need, we can tailor our presentations for your team. Our varied in-house experience allows us to provide general strategic training as well as hands on workshop style training where your team can work through a specific and company related submission document.
How much notice do you need to start a project?
In general we would like enough notice to plan a project well i.e. to agree the key tasks, deliverables and timelines, which we will provide as a proposal. This normally takes about one working week. We understand that business demands mean that this is not always possible and we can be flexible in terms of meeting deadlines. We do always retain a certain amount of office time which can be allocated to clients at very short notice – if we can help, we will!
How can we track the progress of the work as it is being completed?
As part of our commitment to ensuring transparent work practices, we provide each client with a status report at the end of every month. This lists the time spent on each project to the nearest 15 minutes and describes the associated activities undertaken each time a consultant works on your project. A client work report is generated and issued to support each monthly client invoice. These reports are available online also – clients are issued with a password so that access is 24/7.
Can you provide us with ad-hoc advice if we have urgent regulatory or quality systems questions?
Yes, our ability to record work down to 15 minute intervals allows us to provide flexible and ad-hoc advice to our clients. This can often be a telephone or email query or clarification which you require answered before an important meeting. We understand that things do not remain static for our clients and all of our consultants are happy to assist as if we are an integral part of your team including ad-hoc discussions.
Can you provide us with support in determining our regulatory strategy?
Yes, our consultants have significant industry experience, which is invaluable in determining your regulatory strategy. With the assistance of our locally based consultant network we can help you navigate through the directives and guidance on national and European levels, which will allow you to formulate a strategy to address the specific issues affecting your product.
Will you help us learn?
Yes, our aim is to work in partnership with our clients to meet regulatory and quality goals. Part of this process is interaction with the client team and our objective is to help you understand the process so that you will learn as we progress. This helps to build internal expertise for our clients which increases the potential for success and this knowledge transfer gives significant added value for your spend with us.
Will our information remain confidential?
Of course, we sign non-disclosure agreements/confidentiality agreements with all of our clients and providers which protects all of our discussions and documents provided to us. In our industry particularly you’ll appreciate that this is as important to us as it is to our clients.
Do you perform clinical studies?
No we are not a Clinical Research Organisation (CRO) but we can work with you to generate and compile the necessary documentation and obtain the regulatory approvals required to conduct clinical studies. We are always happy to work with your CRO of choice in generating good quality regulatory submissions and to provide oversight and tracking of the regulatory activities.