Business Consulting and Services ·
“Decision-making is easier when your values are clear." Our Value: Prioritizing Patient Safety to Drive Stakeholder Financial Health. Mission: To empower life sciences companies with strategic drug development & life-cycle management solutions that are actionable, ensure patient safety, and enhance commercial success. Vision: To become a trusted advisor that empowers life science companies to achieve breakthrough results. ✅More about services: 💠Medical consultancy: It is offered at every stage of the drug/device development journey, even if no formal documentation is needed at this moment. —————————————— 💠Medical representation: RXVP represents your organization to facilitate KOL/physician discussions, regulatory agency engagement; medical due diligence, and portfolio assessments, to address unmet needs and support strategic decisions. —————————————— 💠Medical writing services: All medical documents that are required during the development and lifecycle management of the drug/device (submissions, query responses, commercialization, post-marketing recalls, etc.). ✅Presubmission stage: Concept notes, Product rationale, TPPs, Clinical trial synopsis, protocols, reports, IB, ICD, CRF & more. ✅Submission stage: Generic, bibliography, 505(B)2 & NDA (eCTD), PIND, IND, iPSP, BioStudy designs, Bio-waivers, Pack-size changes, Rx to OTC switch, PLLR, Safety Reports, Module 2.4, 2.5, SmPCs, Monographs, Formulation/dosage form changes, MDDs, Addressing regulatory medical RFIs during review cycles. ✅Postapproval stage: Pharmacovigilance: DHPC, Health Hazard Assessments (HHAs) for market action decisions, Medical support to BD, and marketing in portfolio extension strategy. ✅Commercial stage: Medical communications, publications, PPTs, addressing market medical requests.