Response to Regulatory Authorities
AllyWorth, supported by the team of experienced professionals, provide a niche support for the preparation of response for any regulatory authority request including but not limited to as below.
- Referral procedures for human medicines [e.g., Article 107i, Article 20, Article 31, Article 29, Article 13, Article 29(4), Article 30] initiated by EMEA.
- Request for Supplementary Information (RfSI) raised by PRAC authority during any ongoing procedures for PSUR / RMP.
- PSUR Follow-up procedures (PSUFU) initiated as an outcome of PSUSA Procedure by EMEA.
- Issue-Related Summary Reports (IRSRs) initiated by Health Canada authority.
- Any other safety related request raised by National Competent Authority (NCA).