Bionumerik Pharmaceuticals

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Description

  • We are a development team comprised of subject matter experts with substantial hands on experience in translational oncology medicine including pre-IND through Phase III/NDA/BLA international oncology development programs. Core Services/Expertise:Structuring of strategic transactions and for due diligence for investmentHow to structure productive university/industry collaborations and partnershipsGAP analyses and strategy for your drug development program from bench to bedside with the aim to cost-effectively achieve the maximum commercial potential for your therapeutic programPreparation for pre-IND meetingsDesign, contracting, and oversight of GLP pharmacology and toxicology studiesDomestic and international Phase I to Phase III trial design, protocol development, feasibility, site selection, and trial management and executionVendor evaluation, selection, negotiation, oversight and management to assure quality, performance and budget compliance - we will save you moneyStrategic planning for commercial development to maximize your investmentEfficient logistics for trial design, implementation, execution, analysis and reportingDrug safety oversight, medical monitoring/assessment, and reporting in compliance with FDA and ICH regulations and guidancesMedical writing for all phases of development, NDA/BLA submissionsInternational regulatory expert services including strategy, communications, meetings, and discussionsStandard operating procedures, policies, and process implementation to enable your company to build an efficient, and compliant operational infrastructure for clinical developmentWe have an extensive international network of key opinion leaders in various disease areas of oncology that we can provide for any development programWe can provide interim management oversight for medical, clinical operations and project management - and help you build your own internal clinical development team
  • location

    Headquarters: , , , United States

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  • Bionumerik Pharmaceuticals phone

    Phone Number:

  • Bionumerik Pharmaceuticals website

    Website: https://www.bionumerik.com

  • Bionumerik Pharmaceuticals employees

    Employees:12

  • Bionumerik Pharmaceuticals revenue

    Revenue:$1 - 10M

  • Bionumerik Pharmaceuticals legal name

    Legal Name:Bionumerik Pharmaceuticals

  • Bionumerik Pharmaceuticals's Social Media

    Bionumerik Pharmaceuticals linkedin
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  • |  NAICS Code: 621111  |

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Director, Regulatory Affairs for Bionumerik Pharmaceuticals

Melanie Mcbride

Director, Regulatory Affairs

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View Employees

Melanie Mcbride

Director, Regulatory Affairs

Jon Badger

Department Head, Information Systems And Technologies

Ed Almaraz

Safety And Facilities Manager

Jean Cheng

Clinical Data Manager

Frequently Asked Questions regarding Bionumerik Pharmaceuticals

  • What is Bionumerik Pharmaceuticals's official website?

    Bionumerik Pharmaceuticals's official website is https://www.bionumerik.com

  • What is Bionumerik Pharmaceuticals's Revenue?

    Bionumerik Pharmaceuticals's revenue is $1 - 10M

  • What is Bionumerik Pharmaceuticals's NAICS code?

    Bionumerik Pharmaceuticals's NAICS code is 621111

  • How many employees are working in Bionumerik Pharmaceuticals

    Bionumerik Pharmaceuticals has 12 employees

  • What is Bionumerik Pharmaceuticals's Industry?

    Bionumerik Pharmaceuticals is in the industry of Pharmaceuticals

  • Who is Bionumerik Pharmaceuticals's Director, Regulatory Affairs?

    Bionumerik Pharmaceuticals's Director, Regulatory Affairs is Melanie Mcbride

  • Who is Bionumerik Pharmaceuticals's Department Head, Information Systems And Technologies?

    Bionumerik Pharmaceuticals's Department Head, Information Systems And Technologies is Jon Badger

  • Who is Bionumerik Pharmaceuticals's Safety And Facilities Manager?

    Bionumerik Pharmaceuticals's Safety And Facilities Manager is Ed Almaraz

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