The Medicinal Chemistry and Synthesis (MCS) Group of the Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), based in Barcelona, is seeking to contract a company specialized in regulatory affairs to prepare a regulatory roadmap aimed at the development of new therapies for which no clearly established regulatory precedents exist.
The selected entity will be responsible for defining a regulatory strategy and roadmap for photopharmacology, an innovative therapeutic platform based on controlling drug activity through light stimuli. Due to its innovative nature and the lack of clearly established regulatory precedents for this type of technology, it is necessary to define a specific regulatory strategy to guide its development.
The scope of the service will include, among other aspects:
- Preparation of a Regulatory Roadmap for the development of photopharmacology-based therapies.
- Identification of regulatory requirements for non-clinical and clinical development through to the first study in humans (First-in-Human, FIH).
Interested companies or professional service providers should submit a technical and financial proposal by 20 September 2026 to the following email address: ramona.galatola@iqac.csic.es
Demonstrable experience in regulatory strategy, interaction with regulatory agencies, and the development of innovative therapies or advanced healthcare technologies will be valued.
The Institute for Advanced Chemistry of Catalonia (IQAC-CSIC) is seeking to hire a specialized company to carry out assay validation and compound evaluation using dopaminergic neurons derived from pluripotent stem cells.
Requirements
- Proven experience in the culture of human neurons derived from pluripotent stem cells.
- Proven capability in the development and validation of cell-based functional assays using iPS-derived dopaminergic neurons.
- Proven capability in assay miniaturization.
- Experience in the application of controlled stimuli (including light stimulation).
- Experience in the quantification of biochemical biomarkers in iPS-derived cells.
- Experience in dose-response curve analysis for compound profiling in HTS (High Throughput Screening) format, providing relevant parameters.
- Capabilities for image acquisition and analysis in HTS format.
Scope of Work
Preliminary Validation
- Initial assays with reference compounds to confirm the correct functioning of the experimental system.
- Optimization of assay conditions, including lighting parameters.
- Definition of assay viability criteria (GO / NO GO).
Assay Validation and Compound Evaluation
- Implementation of the assay in dopaminergic neurons derived from pluripotent stem cells in a miniaturized 384-well multiplate (384 MTP) format.
- Treatment with reference compounds at different concentrations.
- Application of controlled light stimulation protocols, including appropriate control conditions.
- If compatible, evaluation of the cell culture through BrightField image acquisition in 384-well format before proceeding to the final step and, where feasible, quantification of cell density to provide an index
- of cell number (viability) after treatment.
- Quantification of dopamine in the cell supernatant using biochemical methods.
- Evaluation at multiple time points after treatment.
Companies with relevant experience are invited to send their expression of interest to ramona.galatola@iqac.csic.es before June 14, 2026.
