Rhyme Life Sciences Rls

Rhyme Life Sciences(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. We offer: Case processing including receipt, triage, data entry, quality review, medical review, case reporting • Literature activity • Compliance report and periodic dashboard to give oversight on the regulatory and quality compliance • Aggregate reports- PSUR, PBRER, PADERs and Ad-hoc reports requested from the authorities • Signal management- based on the volume of cases, we provide qualitative/quantitative signal detection methods. • Setting up PV system- This include PV policy, SOP preparation, resource estimate, mailbox, internal communication, formation of safety review committee • SDEA process- to sign off SDEAs with all the business partners and to check for compliance to the SDEA • Consultation- to review and provide guidance on the PV system, regulatory queries, Inspection findings, CAPA closure • Audit: To audit the PV and quality system as third part consultant. Also, to audit the partners based on risk assessment • Training- for safety reporting at company level. PV specific trainings to the Drug Safety team. • Preparation of PSMF • Preparation of clinical and non-clinical overview required for dossier submission • Preparation of RMPs • Company specific PSUR tracker as per the EURD list in EU • QPPV/local QPPV services • Preparation of DSUR