Consulting services

Formulation Development

• Identify, develop and evaluate drug formulation and delivery strategies to improve biopharmaceutical performances of drugs and support their lifecycle management.
• Define development strategies and identify the technology platforms available for developing the desired dosage form.
• Development of disinfectants for hospital use.

REGULATORY COMPLIANCE

• Revision of CMC parts of formal submission and registration dossiers for pharmaceutical and biotech products.
• Preparation of reports and protocols to be included in formal submissions or applications for product certification.
• Dossier review and expert reports for applications for Certification of Suitability of Monographs of the European Pharmacopoeia: TSE risk assessment and chemical purity.
• Record auditing in preparation for formal inspections, according to cGMP and cGLP regulations.

Strategic and technical support to start-up companies

• Scientific advice and operational support to R&D and Business Development units in developing their own formulation technologies, drug delivery platforms and pharmaceutical products.
• Strategic evaluation of drug delivery technologies and positioning of internal technology platforms or products pipelines versus competition.
• Scientific and technical support to due diligence operations; evaluation of novel formulations, drug delivery technology platforms and new product opportunities.
• Support in the definition of requirements for different development phases for new drugs (Lead Candidate identification, Preclinical, Phase I), in planning and in management of projects related to such phases.

Professional Training

Training of laboratory and scientific personnel provided at Parc Científic de Barcleona or at client’s facilities. On-site courses can be customized to client’s specific needs to maximize the training effectiveness

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