Guiding you through
regulatory processes
ADRES guides you through every step of the regulatory process, at every stage of development. We take you through the different regulatory stages, drawing on our 30 years of working with regulators in Israel, Europe, the United States, India, Japan, China, South America and Canada.
Our clients rely on our creative regulatory strategies to take their product from early development to Phase 3 clinical trials and marketing.
| Regulatory Affairs | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Regulatory Strategy Develop a regulatory strategy for drug development and approval in European, US, Israel and Rest of the World (ROW) |  | | | ||
| Manage interactions with regulatory authorities, balancing client’s strategy and regulatory authorities’ expectations | | | | | |
| Initiate and perform consultation meetings with regulatory authorities and Notified Bodies, (e.g. scientific advice meetings, pre-IND, EOP2, etc.) throughout the product development lifecycle | | | | | |
| Prepare and submit regulatory documents, (e.g., IND, IMPD, BLA, MAA, RFD, Technical File, Orphan Designation, Pediatric Plan, expedite programs designations as PRIME and Breakthrough and more) | | | | | |
| Consult on clinical trial design and interpretation. | | | |||
| Writing and Compilation of clinical study documentation (e.g., IB, clinical protocol CSR, etc.) | | ||||
| Regulatory, CMC, Pre-clinical and Clinical Gap assessment | | | | | |
| Indication assessment for the potential drug in development from a scientific and regulatory perspective | | | | ||
| Planning Non-clinical program including study design and interpretation | | | | ||
| Product classification according to regulations and classification submissions | | | | ||
| Provide regulatory input to manufacturing and control processes requirements | | | | |
