Enlighten Inc. provides scientific expertise in Project Design and Management, Pre-Clinical Submissions, IND Filing, Assay development and Regulatory Affairs requirements to facilitate your internal project. Our PhD specialists posess direct experience and expertise in the following R&D areas:
- International CMC expertise; critical CMC requirements and process implementation, Project Management.
- Research and Development (SR&ED) Scientific project assessment and summaries for SR&ED tax refund claims.
- US FDA , EMEA, and Canadian TPD Guideline/submission development: scientific support preclinical through clinical studies.
- GLP and ICH Process Implementation; Protocols, reports, archiving and analysis of raw data. Validation of analytical methods. Validation of cell treatment procedures for clinical use. Preparation, qualification and validation of master plans. Writing SOPs, compliance requirements with quality assurance standards.
- Scientific Project Management: Research to IND filing stage in the US and Canada. Preparing scientific reports for IND/CTA filings and annual updates. Successful record of project development and filing within 12 months. Preclinical to Phase I-III Trial requirements.
- CRO/CMO contracted research; evaluation, contract management.
- Bioanalysis, Cell-based Assay; design, SOP requirements.
- Assay Development; design, SOP requirements, genomic and proteomic technology focused.