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life sciences complete quality solutions PQE

From this year, PQE Group can offer support in Drug Development and CMC (Chemistry, Manufacturing and Control).

The new department supports companies in the assessment and commercial exploitation of their projects, from basic research to preclinical development. We work with our clients to develop successful strategic partnerships, improve market and distribution strategies, and evaluate licensing deals. We also leverage our international network in searching for the perfect commercial partner(s) for our clients’ innovative technologies. With a knowledge-driven approach and global network, we can offer an objective perspective in evaluating existing projects, business and new ventures.

Drug development must establish the physicochemical properties of the NCE: its chemical makeup, stability, and solubility. Manufacturers must optimize the process they use to make the chemical so they can scale up from a medicinal chemist producing milligrams, to manufacturing on the kilogram and ton scale. They further examine the product for suitability to package as capsules, tablets, aerosol, intramuscular injectable, subcutaneous injectable, or intravenous formulations. Together, these processes are known in preclinical development as chemistry, manufacturing, and control (CMC).

Capabilities offered from PQE Consultants are divided in:

Drug Development Services

  • Prior Art analysis and Patentability Opinion;
  • Freedom-to-Operate analysis and report;
  • Patent Filling outsourcing support and liaison;
  • Business Evaluation and Competitive Landscape analysis;
  • Market Technology Assessment;
  • Licensing Terms negotiation;
  • Contracts revision;
  • Partners search and selection;
  • Company Internationalization and softlanding activities.

    CMC Services

  • Solid State Characterization of APIs and Finished Products;
  • Preliminary Formulation;
  • Market Technology Assessment;
  • Quality-By-Design Approach;
  • Partners search and selection;
  • Process/Technology Transfer & Scale-up;
  • CMC & Regulatory documentation review;
  • Projects review and Risk Assessment.

    For more info please contact:
    Niccolò Sturli, Sales Service Specialist – Strategic Regulatory & Clinical Affairs, Pharmacovigilance Compliance at n.sturli@pqegroup.com