Rhyme Life Sciences Private Limited(RLS) is established in 2017 with the determination and commitment to offer the Pharmaceutical industry with the solutions which are innovative, and compliance driven thereby meeting the regulatory expectations. We committed to deliver accurate, timely and cost-effective services throughout the regulated markets. We are team comprising of experienced professional including physicians, pharmacists, life science graduates and post graduates. Team is well acquainted with the regulatory needs including but not limited to USFDA, EMA, TGA, CDSCO and others. We are assertive and confident to have 'know how' We are proud to highlight our expertise in handling USFDA and MHRA inspections.

Our services:

1. Literature monitoring: Literature screening, Follow up of lit. reports, screening of non-valid articles, signal report based on non-valid articles
2. Review of MLM source data, xml file(including acceptance and/or rejection)
3. Case processing: Mailbox handling, book-in/log in, triage, data entry, quality review, medical review, case lock, case submission
4. Aggregate report: PSUR(R1), PBRER (R2), PADER, India PBRER
5. RMP: EU RMP, Non EU RMP
6. Signal management: Including signal detection, signal evaluation, prioritising and drafting signal reports
7. Setting up PV system- This include PV policy, SOP preparation, resource estimate, mailbox, internal communication, formation of safety review committee
8. PSMF maintenance
9. SDEA management
10. HHE reports
11. Third party audit
12. Training to partners
13. SPC/PIL comparison
14. QPPV/local QPPV services
15. Preparation of DSUR
16. Consultation on MHRA, USFDA and other Regulatory Inspections. Rich experience in handling the inspections.