Our Regulatory Affairs Department collaborates to promote that every aspect of protocol development, clinical trial management, and documentation complies with applicable regulations and the requirements of the International Conference on Harmonization (ICH).
Regulatory Affairs prepares all regulatory submission, performing quality control reviews. Also we conduct critical appraisal and gap analysis for our clients’ submission and offer solutions early in the development process.
Our services include:
- Development of regulatory strategy
- Guiding clients through the regulatory process
- Client representation before Regulatory Authorities.
- Protocol specific advice: set up and attend meetings with local authorities
- Preparation and review of TMFs ( Trial Master Files)
- Regulatory Support for Clinical Trials
- Request of scientific advice to authorities
- Preparation and Review of Clinical trial applications
- Import/ export authorizations for the supplies employed in the clinical trial
- Medical Regulatory Affairs
- Investigation and selection of pre-clinical and clinical information
- Development of extended and reduced information for prescription
- Regulatory Support for Marketing Authorization
- Preparation of dossier for New Drug Approval Submission
- Review of the dossier for submission to the regulatory agency
- Regulatory aspects of drug supplies management – including labeling and importation requirements
- Product marketing license maintenance ( and renewal)