Ready to Trade in the EU?
Are you already successful in your home markets (e.g. Asia, 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
Going beyond what is expected of a regulatory consultancy, CambReg offers an unrivalled service to clients who have no EU presence and no EU marketing partner
- Provide strategic advice on the best / quickest route to market
- Carry out ‘Gap Analysis’ on EU ready dossiers – our most popular service, representing excellent value during these ‘first steps’
- Compile any part of the CTD, publishing in eCTD if required
- Compile ‘Expert Reports’ for Module 2
- Set up an EU registered Company – less expensively than a legal firm
- Organise EU Health Authority GMP inspection (and mock inspection prior to the official one)
- Manage any Regulatory procedure from start to finish through our network of regulatory associates
- Take care of all the Marketing Authorisation holder's requirements:
- Qualified Person
- Pharmacovigilance /Medical Information
- European Representative Offices
- EU QC & Batch Release
- Act as your EU Regulatory Affairs Department to:
- Maintain Marketing Authorisations
- Review advertising materials
- Apply for Wholesale Dealers and/or Manufacturer's Licences.
- Assume the responsibilities of the MA holder until a marketing partner is found
- Put you in touch with potential marketing partners and/or distributors
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.