Generic

Generic Pharmaceuticals Sector

Introduction

Are you developing a generic of a well-known innovative product? Have you identified a niche in the pharmaceutical market that you can fill with a branded generic product?

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

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

You may need some assistance?

Generic manufactures have huge potential to make significant profit and early ROI due to continuing high demand. The generic markets world-wide are still growing, providing opportunities for companies both new and old. However one wrong move and you could be left with a large stock of product in your warehouse valued at less than you purchased it for. Our advice, particularly for smaller companies, is to proceed but with caution. We have 20 years’ experience in the generics field and project work in this area accounts for 60 to 70% of our revenue making us well placed to help you, especially if you are new to this area.

Time is money – address your Regulatory issues EARLY!

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

Development

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

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

Quality (Chemistry, Manufacture and Control - CMC) Data

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 the main 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 Reference product
• Lack of ‘Tech-Transfer’ data (from manufacturing site to EU batch release sites)

Take advantage of our strong in-house CMC team headed by Dr Mike James (ex-MHRA assessor with more than 30 years' regulatory experience) and choose the most cost-effective route for your products

CambReg’s Services:

• Undertaking a thorough 'Gap Analysis' of your CMC submission documents
• GMP Compliance; Audits & Mock Inspections
• Recommendation of relevant contract houses

Non-Clinical Data

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? Call us to find out Clinical Data

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.

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

CambReg’s Services:

• Providing advice on the optimum clinical programme for your product
• Recommending a CRO to execute your biostudies
• Organising Mock GCP Inspections

Gaining Approval

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.

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

Dossier Compilation

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

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

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 EU wide procedure.

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.

CambReg’s Services:

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

Also Dossier compilation services for:

• EU Certificates of Suitability
• DMF Applications
• TSE Certification

Procedure Management

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

• Pre-submission Audits or Mock-Inspections of Manufacturing Sites
• Pre-submission meetings
• Management of the procedure from Pre-Submission to Post-Approval Phase Commitments
• Liaison with all Relevant Health Authorities throughout the Procedure

Post-Approval

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
• Out licence your MA

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.

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...

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

 

For more information or an estimate, contact us »