A Personal Service from Experienced Professionals

Life Cycle of a Generic

Sound regulatory advice early on in development:

  • Avoids unnecessary development costs
  • Reduces time to market significantly
  • Avoids intellectual property infringements
  • Ensures that you meet data requirements

Introduction

Have you identified a niche in the pharmaceutical market that you can fill with a branded generic product?

Are you developing a generic of a well-known innovative product?

Are you in a race against time to be first to the market after patent expiry of the innovator product?

Do you have the regulatory resource and experience to get your product to the market ahead of the competition?

Time is money – address your Regulatory issues EARLY!

It is a common misconception that "you only need regulatory affairs input when you are ready to submit for approval". This could not be further from the truth because everything that you do during the development phase must be done to standards that will satisfy regulatory authorities.

Allows you to maintain control throughout

With early advice from Cambridge Regulatory Services you can reach your goals faster.

We can help you plan your route, avoid pitfalls and work within your budget.

Critical Issues to Consider:
Have you a fully validated bioassay?
Are you conducting unnecessary studies when a Biowaver is possible?
For pro-drugs, are you monitoring the correct moiety
Are you conducting the correct studies for your non-systemic generic product?

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

Taking early advice on each phase of your development programme means early to market

Are you aware of the latest guidelines relevant to your product?

Do you know enough about the regulatory framework to make it work to your advantage?

What does eCTD  (Electronic Common Technical Document) mean to you?

Cambridge Regulatory Services is here to help you turn your product into a marketed medicine.

Let us provide the regulatory resource and experience at each stage of development:

Quality (Chemistry, Manufacture and Control - CMC)

For a generic product, the quality section of the dossier can be as fulsome as that for a New Chemical Entity, especially if the active is non-compendial.  It is certainly a key component of any generic dossier.

Allow us to highlight and avoid common pitfalls such as:

  • Non-adherence to current EU Guidelines
  • Use of unsuitable batches for Bioequivalence Studies
  • Lack of comparative dissolution in all required media
  • Absence of adequate impurity profiling
  • Use of an unsuitable Comparator
  • Lack of ‘Tech-Transfer’ data (from manufacturing to EU batch release sites)

Have you identified the optimal dissolution test for your product?

Do you know how to show an in vivo/in vitro correlation for your product?

Have you compared the impurity profile of the innovator against your product?

Let us provide the regulatory resource and experience at each stage of development:

Our Services include:

Undertaking a thorough 'Gap Analysis' of your CMC submission documents

GMP Compliance; Audits & Mock Inspections

Recommendation of relevant contract houses

Dossier compilation services for:

  • EU Certificates of Suitability
  • DMF Applications
  • TSE Certification
  • Module 3 and Quality Overall Summary

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

For the majority of Generic applications, there are no new non-clinical data that need to be generated as literature in the public domain can be used to support the product’s safety.

In certain circumstances where you are developing a dosage form different to that of the originator (so called ‘hybrid applications’), then it is possible some non-clinical local tolerance studies may be required. Maybe the impurity profile of your product is such that possible toxicological issues need to be ameliorated before submission (genotoxicity and AMES testing, qualification data etc).

Additional expert input will also be required in this case (Module 2.6 Non-clinical Summary).

Are you able to evaluate whether extra non-clinical studies are required and the nature of these studies?

Will your non-clinical database be in compliance with ICH guidelines?

Is it worth seeking Scientific Advice from the Health Authorities before and during your non-clinical programme?

If you are unsure about any component of your 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.

Let us help you assemble the optimal non-clinical data package and so avoid awkward questions and unpleasant surprises during assessment of your MAA

Clinical Phase

Depending upon the type of generic product you are developing, you may need to conduct clinical trials in order to demonstrate bioequivalence to the originator's product. This will be an important phase for you as for the first time you will be seeing how your product behaves in humans.

For oral dosage forms, bioequivalence studies in healthy volunteers are usually required that demonstrate that your product is therapeutically equivalent to the innovator.  However, in certain circumstances this is not necessary and a ‘biowaiver’ can be applied for.  

In the case of locally acting generic products, the demonstration of bioequivalence is not always possible and the clinical programme can be more complicated. Study data that may need to be generated in this instance include pharmacodynamic data or local availability data (absorption and / or penetration) as well as, local tolerance and possibly in vitro data.

So, in this final phase of development, it is vital  to make sure that you are working with  experts who have had numerous years’ experience in advising on clinical programmes for various generic dosage forms.

Our services include:

  • Providing advice on the optimum clinical programme for your product
  • Writing and Submitting CTAs
  • Seeking Ethics Committee Approval
  • Recommending a CRO to execute your biostudies
  • Mock GCP Inspections
  • Preparing your CTD Module 5
  • Authoring your Module 2 Clinical Overview (and Summary if required)

Have you considered all GCP aspects of your studies?

Are you experienced in preparing CTAs?

Do you need advice on how to optimise your
study protocol (e.g. use of parallel, sequential or steady-state design)?

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.



Our Services include:

 Dossier Compilation:

  • Preparation of all CTD Modules (1-5)
  • Gap Analysis of your dossier
  • Preparation of Product Information (labels, leaflets and SPC)
  • User Testing of Package Leaflets
  • eCTD Publishing (Preferred in most Member States and mandatory for CP submissions)

Procedure Management:

  • Management of the procedure from Pre-Submission to Post-Approval Phase Commitments
  • DCP ‘Slot’ Booking
  • Eligibility requests
  • Pre-submission Audits or Mock-Inspections of Manufacturing Sites
  • Pre-submission meetings
  • Liaison with all Relevant Health Authorities throughout the Procedure
  • Translations

Regulatory Submission Strategy

Do you know?

  • Which regulatory route(s) your product is eligible for?
  • Which countries do you want to access first?
  • If you can get the indications you want in your countries of choice?

The registration route you can take will depend on how the innovator was approved and also your commercial aspirations. 

For example, if you wanted to gain Authorisations in all EU Member States then, if eligible, the Centralised Procedure (CP) maybe your best option. 

In the majority of cases a multistate procedure is followed such as the Decentralised Procedure (DCP) or the Mutual Recognition Procedure (MRP).

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

Dossier Compilation

Plan for early submission by building a CTD dossier as you move through your development programme, reducing time to market by months. Better still, build an eCTD dossier.

Early use of this invaluable tool in product life cycle management will undoubtedly prove to be good long term money and time saving investment.

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.

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 forms the core of our business. Our highly skilled admin support team keep costs down and gets projects completed on time and within budget.

Any or all of these services can go in your Maintenance ‘Package’

We can manage your MA portfolio providing support with:

  • 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)
  • Advice on Sunset Clause Legislation
  • QA System for dossier maintenance (Registered Technical Details (RTD))
  • 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:

  • Gaining the best price for your product (in countries where relevant)
  • Add a new patient group - eg paediatrics through a Paediatric Use Marketing Authorisation (PUMA)
  • Add a line extension
  • Increase the number of ex EU markets with a Certificate of Pharmaceutical Product (CPP)
  • Increase market share by ‘follow on’ legal entity change, e.g. Prescription to OTC

Maintenance Activities

We understand that to maximise your profits you need to keep maintenance activities budget to a minimum.  We are dedicated to this ‘cause’ and strive to tailor our services to suit individual budgets - providing cost effective post-licensing maintenance packages

We believe this approach to post licensing maintenance to be unique. 

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 specialities.

Let CambReg take care of your licence maintenance activities whilst other important submissions are being made.

CambReg has a long established record of supporting clients post-approval….

"Even though timelines can sometimes be very tight, Cambridge Regulatory Services has done their utmost to meet them. They have provided timely responses to the regulatory authorities' questions and shown flexibility… We are happy to recommend Cambridge Regulatory Services to other companies who may need regulatory help. They are a dedicated team who are always willing to provide advice and support."

"We have used Cambridge Regulatory Services to drive regulatory compliance and
to maintain a medicinal license, with great satisfaction. Cambridge demonstrated an admirable ability to take the lead, to drive regulatory strategy and to reflect the corresponding business objectives. Negotiation between various parties involved, as well as challenges associated with navigating through an old dossier and against timelines was managed with professionalism and confidence.

On a personal level, the team were very approachable at all times and access to their knowledge base was a real asset during the project. It was a pleasure to work with every member of the Cambreg team.

I look forward to working with Cambreg again in the future and will have full confidence in their ability to deliver quality and timely results."

K.D, Director Regulatory Affairs
Sciele Pharma

Your Partner of choice for a full Regulatory Service