FORMULATION AND PRODUCT DEVELOPMENT
Identify, develop and evaluate drug formulation and delivery strategies to improve biopharmaceutical performances of marketed drugs and support their lifecycle management.
Define development strategies and identify the technology platforms available for developing a novel dosage form or modified molecule with improved biopharmaceutics.
To expand its offer in formulation and product development, SiTec signed a collaboration agreement with Messer Group GmbH, in-licensing a novel, solvent-free, dense gas technology, for the development of pharmaceutical products as fine powders or microspheres with improved drug delivery properties.
More information about our cryospraying technology and its application in drug delivery can be found in SiTec PharmaBio website.
STRATEGIC AND SCIENTIFIC SUPPORT TO STARTUP AND DEVELOPING COMPANIES
Scientific advise 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.
DEVELOPMENT OF DISINFECTANTS FOR HOSPITAL USE
Support and manage experimental programs to develop disinfecting formulations for hospital use, to disinfect patients' skin prior and after surgery, or for the disinfection of surgical equipment.
- Stabilization of the disinfecting formulation
- Excipients selection and impact on formulation stability and efficacy
- Compliance with current regulations
- Patient compliance
DOCUMENTATION AND 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.
Direct training of laboratory and scientific personnel, provided at BioIndustry Park and on-site at clients' facility.
SiTec is an authorized representative for the Center for Professional Advancement. The CfPA is a private educational institution dedicated to the provision of continuing technical and scientific education at a professional level.
Client-site courses programs can be customized to Companies' specific needs or interest to maximize training effectiveness.