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Mission statement

QSCL provides regulatory drug development strategy and project management services to the pharmaceutical industry. QSCL is committed to providing efficient, cost effective pharmaceutical product development in partnership with our clients, through first-class regulatory and scientific advice.

 

General service offering

QSCL’s extensive experience in drug development includes management of nonclinical and clinical studies at CROs and providing consultants in a wide range of regulatory and specialised areas.  Colleagues at QSCL provide an in-depth knowledge of the complete pharmaceutical product development and life-cycle management process based on direct experience with:

    • numerous NCEs, route switches, line extensions and generic products;
    • strategic and operational management  of development and regulatory activity, including several large product portfolios;
    • dozens of meetings for various development phases with EMA,  and EU and USA national agencies;
    • regulatory support of approximately 20 preparations for launch;
    • a wide variety of MA variations or and several changes of ownership;
    • regulatory due-diligence: dossier defence and review for out- and in-licensing respectively;
    • in-house staff training.

Regulatory submissions have included the following:

    • regular Scientific Advice from EMA and main EU agencies;
    • numerous CTA Applications including IMPDs and IBs;
    • more than 100 generic applications including  at least 10 DCP Abridged Applications, plus several line extensions;
    • Marketing Authorisation Application (MAA) CTD Modules 1-5  and follow-through to grant of MA;
    • Orphan Drug and Ethics applications;
    • FDA Pre-IND meetings, using established USA regulatory relationships as required.

Companies associated with QSCL have periodically provided specialist services to QSCL’s clients:

  • Nonclinical:
    • genetic and reproduction toxicolology, effects on QT and metabolism;
  • Quality:
    • inhalation formulation and devices, sterile manufacture and QA, medicinal chemistry;
  • Clinical:
    • target product profile, supervision of bioanalysis and multinational studies, QA.