Who we help > New to Europe / Brexit

New to Europe / Brexit

New to Europe / Brexit

Ready to Trade in the UK/EU?

Concerned about Brexit?

Are you already successful in your home markets (e.g. India, China or the Americas) and now considering marketing your products in the EU?

We can provide all you need to allow you to capitalise on providing Medicines to one of the world’s most lucrative markets.

CambReg is the leading service provider for regulatory affairs solutions for Mumbai and Maharashtra based clients, having helped dozens of Indian clients on their way to success in the European Union. Understanding that our clients want value for money at every stage has made CambReg such a popular choice.

Testimonials from satisfied clients are available on request

Our Services

Going beyond what is expected of a regulatory consultancy, CambReg offers an unrivalled service to clients who have no UK/EU presence and no UK/EU marketing partner

First Steps

  • Set up an UK/EU registered Company – less expensively than a legal firm. We have offices in the UK and Cyprus
  • Provide strategic advice on the best / quickest route to market
  • Organise EU Health Authority GMP inspection (and mock inspection prior to the official one)
  • Put you in touch with potential marketing partners and/or distributors
  • Apply for Wholesale Dealers and/or Manufacturer's Licences.

Dossier Preparation

  • Carry out ‘Gap Analysis’ on UK/EU ready dossiers – our most popular service, representing excellent value at this early stage
  • Compile any part of the CTD, and publish in eCTD
  • Compile ‘Expert Reports’ for Module 2

Procedure Management

  • Manage any Regulatory procedure from start to finish through our network of regulatory associates

Marketing Authorisation holders Responsibilities

Take care of the Marketing Authorisation holder's liabilities:

  • Qualified Person
  • Pharmacovigilance /Medical Information
  • European Representative Offices
  • UK/EU QC & Batch Release

Post Licensing

  • Act as your UK/EU Regulatory Affairs Department to:
  • Maintain Marketing Authorisations
  • Review advertising materials
  • Assume the responsibilities of the MA holder until a marketing partner is signed up

From Concept to Patient - We do just as much or as little as you want

Training in EU Regulatory Affairs

In response to feedback from clients who do not want to be reliant on consultants long term we are now offering training in various forms.

Please call for a tailored solution.

No UK/EU presence? No problem! Just give CambReg a call

Concerned about Brexit? We can advise on how it may affect you

Note At the time of writing (August 2019) the UK is still part of the EU

The European Union currently consists of 28 sovereign member states and each member state has its own national regulatory body, generically referred to as the ‘Competent Authority (CA). Each CA has its own unique name e.g. UK has the Medicines and Healthcare Products Regulatory Agency (MHRA). 

Names and contact details for all the agencies can be found at hma.eu

There is also a central body for authorisation of novel, high tech and biotech medicines called the European Medicines Agency (EMA) .

Iceland, Liechtenstein and Norway are also part of the EU regulatory arena and are allowed to trade in the single EU market without EU membership as they are members of the European Economic Area (EEA)

We have set up a new company, CambPharma Solutions Ltd (CY) in Cyprus to enable us to continue to operate within the EU

For more information or an estimate, contact us »

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