Harten Group

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Accessing European markets

Located in Cambridge UK at the heart of the largest cluster of biotech and pharmaceutical companies in Europe, Harten Group has over 16 years' experience and over 2000 experienced pharmaceutical consultants in its established network. This geographical positioning and extensive network have allowed Harten Group to be the local partner of choice for many pharmaceutical, biotech and medtech organisations seeking entry to and support within the EMA region.

Working through Harten Group allows client life sciences companies based in North America and Australia to access European healthcare markets for both corporate and product development. Staff travel frequently to Australia and the US and are available for face-to-face meetings. Bridging through the UK into Continental Europe also overcomes language barriers.

Harten Group offers a tailored service including:

  • Deep understanding of both foreign healthcare models and providers
  • Entry to European markets using native language speakers
  • Establishment of European subsidiaries, headquarters and management teams
  • Clinical trials planning and management
  • Medico-marketing support
  • Advice on bio-pharmaceutical and medical devices' pricing and reimbursement
  • Clinical market research programmes
  • Pharmacovigilance and post marketing surveillance studies
  • Regulatory support during clinical development including risk management plans
  • Ongoing liaison with national healthcare regulatory authorities throughout Europe
  • Interim medical directors.

Harten Group is integrated into the EMA and National Healthcare Regulatory Authorities and is positioned to ensure that clients comply with all local laws and regulations. It is also able to assist with obtaining NICE approvals and writing Health Technology Assessments.

Working with Harten Group allows client companies to make an immediate strategic impact in Europe and avoid the pitfalls and mistakes that are often made during a learning process. Using our well-established outsourcing model ensures flexibility of approach from large-scale development projects, to discrete 'modular' technical reports or client-managed interim expertise on the ground, in Europe.

As a US-based company, we lacked in-depth knowledge of European markets and regulations and needed this information for a potential product roll-out. It would have been extremely costly and time-consuming to send a team over there but Harten Group was able to help by tapping into its established network and accessing key opinion leaders in the field. The result was a comprehensive report providing all the details we needed without us even having to take a transatlantic flight!

VP Marketing, Top 10 US Pharm

 

Latest assignments

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Recent projects & updates

A consultant has been helping a generics company headquartered in Ireland, currently branching into branded pharmaceuticals, with training and raising awareness of the Code to ensure local and UK compliance.

Harten Group consultant handles all regulatory requirements for compiling and submitting monthly safety updates for a global pharma company's antiviral during flu epidemic.

Read full details >>