Life Cycle of a Small Molecule Product

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?

Our Services include but are not limited to:

Quality (Chemistry, Manufacture and Control - CMC)

• Gap analysis
• GMP Compliance; Audits and Mock Inspections
• Recommendation of relevant Contract Houses
• Dossier Compilation Services for:
• EU Certificates of Suitability
• DMF Applications
• TSE Certification
• Module 3 and Quality Overall Summaries

Non-Clinical Phase

• Review of and advice on your non-clinical programme
• Recommendation of Contract Houses for your pre-clinical studies
• Recommendation of opinion leadersin your field
• Arranging GLP Compliance Mock Inspections
• Preparing your CTD Module 4
• Authoring your Module 2 Overview and Summary

Quality (Chemistry, Manufacture and Control - CMC)

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:

• Route of synthesis unsuitable for the non-clinical and clinical programme
• Production methods not being commercially scalable
• Genotoxic impurities not investigated or investigated too late
• Non-appreciation of polymorphism and its possible implications

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.

Non-Clinical Phase

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.

Clinical Phase

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.

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?

Our Services:

Dossier Compilation:

• Gap analysis
• EU Risk Management Plans (RMP)
• Environmental Risk Assessments (ERA)
• Preparation of Product Information
• User Testing of Package Leaflets
• eCTD Publishing

Procedure Management:

• From Pre-Submission to Post-Approval
• Eligibility requests
• Pre-procedural meeting
• Pre-submission requests
• Advice on Product Name
• Requests for Accelerated Approvals
• Advice on fee waivers
• Preparation for Pre-Approval Inspections

Regulatory Submission Strategy

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).

Dossier Compilation and Procedure Management

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.

No EU presence? No problem!

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.

Our Services:

We can manage your MA portfolio and provide:

• Advice on Sunset Clause Legislation
• Optimum variation submission strategies
• Periodic Safety Update Reports (PSUR)
• Renewals
• Annual Safety Reports (ASR)
• Change of Ownership
• Pricing and Reimbursement
• Vetting and Advertising Materials
• QA System for dossier maintenance (Registered Technical Details (RTD))
• Pharmacovigilance services

Opportunities

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:

• Prepare for an indication or line extension
• Learn how to protect from parallel imports
• Increase the number of markets outside the EU with a Certificate of Pharmaceutical Product (CPP)
• Increase market share by legal entity change, e.g. Prescription to Over The Counter
• Push the boundaries with your advertising material

Maintenance Activities

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