For all your Regulatory Affairs challenges

Life Cycle of a Biotech

Do you fully understand the biotech regulatory framework?
Are you aware of the latest guidelines relevant to your product and its therapeutic area?
Do you need to obtain US and EU Scientific Advice to avoid data duplication?

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.

The clock is ticking – don’t leave Regulatory issues until last

Are you on the brink of a new biotech drug breakthrough?

Having obtained protection for your discovery you now have to move fast to take full advantage of your patent.

The key to success is to plan ahead and spend your R&D budget wisely 

No need to go it alone!

We 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

As your partner from discovery to patent expiry and beyond, we work with you to the best commercial advantage of your product at any stage.

Your Partner of choice for a full Regulatory Service

CambReg can help

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 during development of your product and such is the complexity of biotech molecules that using highly skilled professionals is a must.  

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

  • Lack of appreciation of process parameters and unit operations that impact critical quality attributes (CQAs)
  • Route of synthesis being unsuitable for the Non-Clinical and Clinical Programmes
  • Purification systems not appropriate, justified or adequately validated
  • Being out of date with regards to the ever changing regulations on adventitious agents
  • Lack of adequate cell-line characterisation

Our biotech knowledge and experience can help you decide on your route of synthesis before you embark on your clinical programme.

 

Will you have enough material to start your preclinical studies?

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

Have small manufacturing changes had an effect on product safety and efficacy?

Have you optimised your delivery system yet?

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 products.

Non-Clinical Phase

Moving to the non-clinical phase you face fresh challenges. 

Unlike conventional medicinal products the quality, safety and efficacy of biotechnology products are intricately linked, leading to the need for a smooth and well-informed transfer from the quality stage to non-clinical safety testing.  In addition, conventional non-clinical testing guidelines for small molecule are often not relevant for biotechnology products and there is a need to keep up to date with regulatory developments.

It’s wise to seek regulatory input at this stage Only 1 in 250 compounds will make it.

Would you like to know if you are on the right track with your pharmacology and toxicology studies?

Do you require regulatory experts who understand the PK and PD of biotech and biologic products?

Have you considered the possible clinical consequences of any non-neutralising and neutralising auto-antibodies?

Only 1 in 250 compounds will make it through this phase -  Acting on advice from your regulatory partner can only increase your chances of success.

CambReg’s 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 costly phase of development, 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 expensive in terms of time not just money. 

Be sure you have the right answers:

Does your bioassay adequately distinguish your therapeutic protein from endogenously produced equivalents?

Do have any sufficient PK/PD data to reduce the need for some clinical studies?

Have risk factors been identified for any first in man studies?

What impact will the EU Paediatric Regulation have on your clinical programme?

Allow CambReg to help you over the final regulatory hurdles

We will champion your product and remain dedicated to the project until your medicine has reached the market and is benefiting patients.

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 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?
  • When you need to start dialogue with the regulators?

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

As you will have to submit your 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, reducing time to market by months.

For submissions via the Centralised Procedure, dossier preparation and dialogue with the Authorising Body (European Medicines Agency (EMA)) needs to commence, ideally,  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
  • Pharmacovigilance services

Your Marketing Authorisation is a very valuable - Make the most of it!

Opportunities

Post-licensing activities need not be a non-profit generating burden.

Consider these activities to exploit your products to their full potential:

  • Add a new indication or patient group
  • Develop easier more comfortable routes of administration to add as line extensions
  • Increase the number of ex EU markets with a
  • Certificate of Pharmaceutical Product (CPP)
  • Push the boundaries with your advertising material

Maintenance

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.
Licensing in or out?

Due diligence is one of our specialties.

"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