A Personal Service from Experienced Professionals

Life Cycle of a Biosimilar

Can your product be handled as a biosimilar from a regulatory perspective?
Are you aware of the differences in regulatory requirements in the USA/EU?
Have you fully considered then implication of any differences to the Reference Product?

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

Are you developing a ‘generic’ version of a novel biological medicine?

You are now in a race against time to make sure that you will be first to the market after patent expiry of the innovator product.

You can get ahead if you start thinking about Regulatory issues NOW

It is a common misconception that you only need to consider regulatory affairs when your development phase is complete". This could not be further from the truth because everything that you do from this stage onwards must be done to standards that satisfy regulatory authorities in your chosen markets.  

Make sure that you have the regulatory resource and experience to get your candidate product to market ahead of the competition.

There’s no need to go it alone!

CambReg can help by:

  • 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.

Taking early advice on your development programme means early to market.

Only 1 out of 10,000 lead compounds make it to the market*.
As somebody who has over 25 years’ experience in pharmaceutical R&D, I found the performance of Cambridge Regulatory Services Ltd to be way above average for regulatory affairs consultancies and would not hesitate to use their services again”.

(Jon Dickens - ENACT)

Make sure you can satisfy Health Authorities in the EU, USA and Japan with one data package.

Our Services include:

Dossier Compilation Services for:

  • Vaccine Antigen Master File Applications
  • Plasma Master File Applications
  • Module 3 and Quality Overall Summaries

Quality (Chemistry, Manufacture and Control - CMC)

You know and we know that there will be CMC issues throughout the life of any product and biosimilar products present additional development challenges because of their greater complexity.

Get ahead of the competition by learning from us how to spot and avoid common pitfalls are such as:

  • Poor identification of minor differences in structure (e.g. post-translational modifications)
  • Flawed criteria used in selecting the Reference Product
  • Production methods not being commercially scalable
  • Lack of justification for impurity-profile differences

Will you have enough material to start your preclinical studies?

Have you considered immunological properties to design your proof-of-concept studies?

Do your manufacturing standards comply with regulatory requirements?

Our biotech knowledge and experience can help you decide on your CMC strategies before you embark on your clinical programme.

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 most cost-effective route for your product

Non-Clinical Phase

At this stage you will be required to carry out intensive in vitro testing generally coupled with studies in various animal species.

Is one study enough to obtain the necessary PK, PD, toxicity and immunogenicity data?

Have you considered immunological properties to design your proof-of-concept studies?

Have you considered species specificity and other factors prior to your studies?

Do you need to assess toxicokinetics and recovery?

If you are unsure about any component of the non-clinical development, the solution is to outsource.

This will be a key element in getting the work done in an efficient and timely manner.

Our Services include:

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

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 most costly phase, it is vital  to make sure that you are working with experts.

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 substitute confirmatory clinical trials with pharmacodynamic studies?

Have you considered obtaining Scientific Advice
from the regulators for your immunogenicity issues?

Have you fully defined and justified your a priori equivalence margin?

Our Services:

In this busy phase we can help you get ahead with:

  • Clinical programme advice
  • CTA (Writing and Submission)
  • Ethics Committee Approval
  • Recommending opinion leaders
  • Recommending a CRO to execute your  clinical trial programme
  • Mock GCP Inspections
  • Preparing and User Testing of Product Information (Labelling and Leaflets)

Authoring and Testing Subject Information Sheets (SIS)

Take advantage of our knowledge and experience during this important phase of your product development

 


Our Services:

Dossier Compilation:

  • Gap Analysis
  • Preparation of all CTD Modules (1-5)
  • Writing EU Risk Management Plans (RMP)
  • Writing Environmental Risk Assessments (ERA)
  • Preparation of Product Information (labels, leaflets and SPC)
  • User Testing of Package Leaflets
  • eCTD Publishing (mandatory for the Centralised Procedure)

Procedure Management:

  • Management of the procedure from Pre-Submission to Post-Approval Phase Commitments
  • Pre-procedural meeting
  • Pre-submission requests
  • Advice on Product Name
  • Eligibility requests for Accelerated / Conditional Approvals
  • Advice on fee waivers / reductions
  • Preparation for Pre-Approval Inspections (GMP / GCP)

Regulatory Submission Strategy

Do you know?

  • Which regulatory route(s) your product is eligible for?
  • What is the legal basis of your submission?

We can devise an optimum submission strategy that combines both your commercial and regulatory needs.

As you will have to submit your biosimilar EU 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 (saving 3-6 months).  

For submissions via the Centralised Procedure, dossier preparation and dialogue with the Authorising Body (European Medicines Agency (EMA)) needs to ideally commence at least 12 months before the intended submission date.

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 of Advertising Materials
  • Guidance on submission of post-approval data (including paediatric)
  • QA system for dossier maintenance (Registered Technical Details (RTD))
  • Pharmacovigilance services

Opportunities

Take full advantage of your very valuable asset!

Post-licencing need not be a non-profit generating burden.

We would like to advise you on post-licencing activities that will allow you  

to exploit your products to their full potential such as:

  • Prepare for a new indication or line extension
  • Learn how to protect from parallel imports
  • Increase the number of ex EU markets with a

Certificate of Pharmaceutical Product (CPP)

  • Investigate the possibility of ‘biosuperiors’
  • Push the boundaries with your advertising material

We at CambReg have put together a unique cost effective post-licencing ‘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. (Read more here...)

Licensing in or out?

Due diligence is one of our specialties.

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. (Read more here...)

Guidance on submission of post-approval data (including paediatric) QA system for dossier maintenance (Registered Technical Details (RTD))

Pharmacovigilance services.

"For those who require professional regulatory support and advice with the personal touch, I would not hesitate to recommend Cambridge Regulatory Services"

O.M.

Besins International

Your Partner of choice for a full Regulatory Service