Q Scientific Consulting Limited (QSCL) provides a service based on decades of international experience in regulatory drug development, including exposure by inhalation:
- regulatory & scientific strategy for preclinical and First-time-in-Man studies
- document preparation for project team and regulatory submissions
- cost-effective placement and management of First-time-in-Man, preclinical and bioanalytical studies at CROs
Since 1997, QSCL has provided consultancy and training services in early-stage development of respiratory pharmaceuticals and fine chemicals.
QSCL can support your early stage strategic planning, design the necessary studies and then procure and manage outsourcing of studies where required.
Principal activities are outsourcing preclinical toxicology and bioanalysis to EU & North American contract research organisations, and then preparing regulatory documents.
QSCL provides your project team with an economical and seamless interface to your first clinical studies.
Clinical activities include:
- management of First-time-in-Man and Proof of therapeutic Concept
- work with Ethics Committees on the EU Clinical Trials Directive
- pharmacokinetic & bioanalysis and sample management
- dialogue with regulatory authorities including MHRA
Current research interests include:
- nasal pulmonary deposition
- therapy for sexual dysfunction
- lung metabolism and cytochrome p450
- pulmonary sensitisation & inhalation sensitisation
- clinical & preclinical QT prolongation
- inhalation therapy for asthma
Previous experience within 3 major UK and Canadian CROs included exposure by all clinical important routes, including inhalation.
Experienced in the early stage development of New Chemical Entities (NCEs), biotechnology products and some device types.
QSCL is experienced in setting up and managing scientific advisory meetings with regulators
- pulmonary function & irritancy testing
- inhaled anaesthetics and metered dose inhalers
- inhaled biotechnology products
- mucoactives, bronchodilators, and major products for diabetes & cystic fibrosis
- biotechnology and New Molecular Entities (NMEs)
- all clinically important routes of administration