Proven methodology for long term success

Confidence Beyond Compliance

The biopharmaceutical sector already makes up at least 20% of the global pharma market with a foreseeable growth in the future. Reasons for this are the outstanding efficacy and safety of these complex molecules, and their high potential to address historically untreatable conditions. The development and production of biopharmaceuticals are both challenging and evolving rapidly, and so are the associated regulatory expectations and pathways to approval. It is essential to account for regulatory requirements early on and to carve out the most efficient path to approval to ensure commercial success.

PharmaLex are able to offer an integrated solution combining the scientific, technological, nonclinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.

We Support a Range of Products

  • Recombinant proteins (including mAbs (and derivatives), hormones and enzymes)
  • Biosimilars
  • Peptides
  • Vaccines (recombined proteins, live attenuates bacterial vectors, viral vectors)
  • Cellular tissue cell and
  • Gene therapies / ATMPs

PharmaLex Offers Support In These Area

  • Clinical Development
  • Discovery / Non-Clinical
  • Market & Launch
  • Product Maintenance

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