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Our Services
Strategic insights at every stage of drug/device development, even if formal documentation is not required at the moment.
RXVP facilitates KOL/physician discussions, regulatory agency engagement, medical due diligence, and portfolio assessments.
Comprehensive medical documentation support across submission, regulatory review, and commercialization & recall stages.
We do not represent any one tool or vendor; our focus is on aligning the right AI solution with the right business problem in the right way.
It is offered at every stage of the drug/device development journey, even if no formal documentation is needed at this moment.
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.
All medical documents that are required during the development and lifecycle management of the drug/device (submissions, query responses, commercialization, post-marketing recalls, etc.).
Concept notes, Product rationale, TPPs, Clinical trial synopsis, protocols, reports, IB, ICD, CRF & more.
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.
Pharmacovigilance: DHPC, Health Hazard Assessments (HHAs) for market action decisions, Medical support to BD, and marketing in portfolio extension strategy.
Medical communications, publications, PPTs, addressing market medical requests.
2024
Drug Development Strategies, Medical Expertise , Health Hazard Assessment/Market Action, eCTD- Module 2.4, 2.5, 2.5.2, Clinical Trial documents, Generic Filings, PLLR format PIs, Responding to regulatory medical queries , Responding to physicians and patients , Target Product Profiles, Medical Rationale/Medical support for Prescription to OTC switch/Pack size changes, 505 (b)2 filings, PIND & IND/NDA, Scientific Advice, Bioequivalence study designs/waivers, Monographs/SmPCs/PIs, New drug proposals, Pipeline assessment, Protocol Synopsis/End points, CSR, DHPCL, Medical opinion about ICSR-outside ARGUS, Medical expertise assistance at commercialization stage, Product Life-cycle Extension, Regulatory medical writing, Commercial medical writing, Medical publications, Any project requiring medical expertise, and Drug/device portfolio discussion