Do you fully understand the regulatory framework in which you need to work?
Are you aware of the latest guidelines relevant to your product and its therapeutic area?
What does CTD (Common Technical Document) mean to you?
Providing honest unbiased regulatory advice
Supplying information on latest relevant guidelines
Provide you with a full understanding of the regulatory framework
Recommend Experts in your field
Recommend Contract Houses for subsequent development
Are you working on a promising new drug development programme for a novel small molecule?
Then you will be aware that:
Only 1 out of 10,000 lead compounds make it to the market!
The key to success is to plan ahead and spend your R&D budget wisely.
Your discovery may be protected BUT you now have to move FAST to take full advantage of your patent
Taking sound regulatory advice early on in the programme can:
Add value to your project for your Investors
Avoid wasting money on unnecessary trials
Reduce time to market significantly
Increase profits by having a longer unopposed sales period
We can work with you as part of your project group, from discovery to patent expiry and beyond, advising along the way, to ensure that your product gives you the best commercial advantage at every stage.
If your product is for a rare disease, it may be eligible for Orphan Drug Designation. Let us tell you about the commercial advantages that designation brings.
Get to market faster with help from CambReg
Will you have enough material to start your preclinical studies?
Are you embarking on key studies with material with an unrepresentative impurity profile?
Will you have enough stability data to support your Clinical Trial Application?
You know and we know that there will be CMC issues throughout the life of your product.
Get ahead of the competition by learning from us how to spot and avoid common pitfalls such as:
The answers are a little more than a phone call away.
Take advantage of our strong in-house CMC team headed by Dr Mike James (ex-MHRA assessor with more than 20 years' regulatory experience) and choose the fast track for your products.
Having reached this stage your chances of reaching the market with your discovery compound have increased forty-fold
Still only 1 in 25 compounds will make it
Acting on advice from your regulatory partner can only increase your chances of success.
We can point you in the right direction by asking the ‘right questions’.
Would you like to know if you are on the right track with your pharmacology and toxicology studies?
Do you need carcinogenicity studies?
Will your non-clinical database be in compliance with ICH guidelines?
Using a pragmatic approach and good arguments, we could help you satisfy the regulators with a less costly and streamlined non-clinical programme.
In this final and most costly phase of development, it is vital to make sure that you are working with experts.
Currently, product success rates from first-in-man studies to registration are approximately 11%
Make sure you are one of the 11% by allowing us to champion your product.
Mistakes at this juncture can be very expensive. Get us involved early on in your clinical phase programme and allow us to advise you on critical issues to consider which, if ignored, will be costly in terms of time.
Can you provide evidence that your product is cost-effective; knowing that post approval you will face the 4th hurdle?
Are there any ethnicity issues with regards to trials conducted ex EU?
What impact will the EU Paediatric Regulation have on your clinical programme?
A paediatric investigation plan (PIP) needs to be considered as early as Phase 1.
Have you considered all potential patient populations (including geriatrics)?
Having come this far allow us to get you over the final regulatory hurdles. We will remain dedicated to the project until your medicine has reached the market and is benefiting patients.
||In this busy phase we can help you get ahead with:
Take advantage of our knowledge and experience during this important phase of your product development.
Do you know?
Which regulatory route(s) your product is eligible for?
Which countries you want to access first?
We can devise an optimum submission strategy that combines both your commercial and regulatory needs. As it is likely you will want to (or may have to) submit your EU NCE dossier via the Centralised Procedure (CP), we can suggest ways in which you can get your product to the market faster (e.g. Accelerated / Conditional Approvals) and cheaper (fee waivers/ reductions).
Plan for early submission by building an eCTD dossier as you move through your development programme, reducing time to market by months.
Whatever route you take, you should also start dialogue with the regulators as soon as possible.
If your company does not have an EU presence we can assume the responsibilities of the MA holder until you find a marketing partner.
Are you seeking EU-wide registration and don't have presence in all EU member states?
We can manage your procedure through our network of regulatory associates.
Dossier compilation and advising on regulatory procedures form the core of our business.
Our highly skilled admin team helps to keep costs down and projects moving.
Post-licensing need not be a non-profit generating burden.
We would like to advise you on post-licensing activities
that will allow you to exploit your products to their full potential:
We at CambReg have put together a unique cost effective post-licensing ‘package’ that can be adapted to suit your post-licencing needs whatever they are.
No EU regulatory expert in-house?
We can maintain your MA portfolio until you have reached a size where it becomes essential to have your own in-house regulatory staff.
Licensing in or out?
Due diligence is one of our specialties.
Start the regulatory process over again with a Line Extension?
Your Partner of choice for a full Regulatory Service