Pravin Soni

Pravin Soni Email and Phone Number

President at PharmaCRO, LLC @
Pravin Soni's Location
Sunnyvale, California, United States, United States
Pravin Soni's Contact Details

Pravin Soni personal email

n/a

Pravin Soni phone numbers

About Pravin Soni

* Consultant with over 30 years of experience in development, manufacture and registration of novel drug, device and combination medical products, with emphasis on creating value through intellectual property development. Sixty three (63) patents.* Strategic perspective that integrates design, manufacturing, quality, regulatory, clinical, toxicology, and marketing requirements to identify the least burdensome and most efficient route to commercialization of safe and reliable products* Experience with successful FDA interactions relating to CMC aspects of drug, device and combination medical products development, from early through late stagesEXPERTISE: CMC: Drug, device and combination productsRegulatory: Dev. of least burdensome strategyNon-clinical: Dev. of non-clinical programIntellectual property: Extracting proprietary content from product concepts to fashion effective patent applicationsProject Management: Management of interactions between functional areas involved in developmentProduct development strategy: Based on clinical need, available therapies, technical core competencies and competitive landscape

Pravin Soni's Current Company Details
PharmaCRO, LLC

Pharmacro, Llc

President at PharmaCRO, LLC
Pravin Soni Work Experience Details
  • Pharmacro, Llc
    President
    Pharmacro, Llc Oct 2020 - Present
    Sunnyvale, California, United States
    Consultant in Chemistry, Manufacturing and Control (CMC); Regulatory Affairs; Quality; IP* Product design and development for drug, device and combination medical products. * Manufacturing development, from early stage for clinical trials, through scale up for Phase 3 and commercial launch* Development of efficient Quality systems for both device (QSR) and drug (cGMP) development.* Development of strategy for least burdensome approach for regulatory approval of the product under development. Product Development Planning:* Plan for product development / Project Management, including interactions between the various functional areas that are involved in the development process (Design/Formulation, Non-clinical, Clinical, QA/QC, Marketing, Manufacturing, Regulatory, Facilities, Finance/ Budgeting, Intellectual Property) to effect a successful outcome for the development process that is on-time and on-budget
  • Respivant Sciences, Inc
    Executive Vice President, Respivant Sciences, Inc
    Respivant Sciences, Inc Sep 2018 - Oct 2020
    San Diego, Ca
  • Respivant Sciences, Inc
    Exec. Vice President
    Respivant Sciences, Inc Sep 2018 - Oct 2020
    San Diego, Ca
    Head of development: CMC, CMC/Regulatory and Quality; Intellectual Property
  • Respivant Sciences, Inc
    Exec. Vice President
    Respivant Sciences, Inc Sep 2016 - Oct 2020
    San Diego, Ca
  • Patara Pharma, Llc
    Chief Technical Officer
    Patara Pharma, Llc Jul 2014 - Oct 2020
    San Diego, Ca
    Patara is developing treatments for rare diseases using the pulmonary route of administration
  • Elevation Pharmaceuticals
    Sr. Vice President And Cto
    Elevation Pharmaceuticals Jul 2011 - Sep 2012
    San Diego
    Senior Vice President and Chief Technical Officer, responsible for development of a combination product using nebulized glycopyrrolate for the treatment of COPD. Elevation was successfully acquired by Sunovion Pharmaceuticals for $430MM in Sept 2012
  • Pharmacro, Llc
    President
    Pharmacro, Llc Apr 2007 - Jun 2011
    Consultant in Chemistry, Manufacturing and Control (CMC): * Product design and development for drug, device and combination medical products. * Manufacturing development, from early stage for clinical trials, through scale up for Phase 3 and commercial launch* Development of efficient Quality systems for both device (QSR) and drug (cGMP) development.* Development of strategy for least burdensome approach for regulatory approval of the product under development. Product Development Planning:* Plan for product development / Project Management, including interactions between the various functional areas that are involved in the development process (Design/Formulation, Non-clinical, Clinical, QA/QC, Marketing, Manufacturing, Regulatory, Facilities, Finance/ Budgeting, Intellectual Property) to effect a successful outcome for the development process that is on-time and on-budget.
  • Finisar Corporation
    Consultant
    Finisar Corporation 2009 - 2010
  • Arbor Vita Corporation
    Consultant
    Arbor Vita Corporation 2007 - 2009
    View
  • Alexza Pharmaceuticals
    Vp Product R&D
    Alexza Pharmaceuticals Oct 2002 - Apr 2007
    Responsible for project management, product design, process development, and pre-clinical and clinical manufacturing for inhalable drug delivery systems (combination products) that are compliant to the US (FDA, DEA, DOT and ATFE) and EU regulations. Company Officer and member of the Executive Staff.
    View
  • Cygnus Inc
    Vice President, Engineering
    Cygnus Inc 1994 - 2002
    * Responsible for formulation, product design and process development for transdermal systems* Responsible for product development, manufacturing equipment design, manufacturing process development and scale-up for a non-invasive continuos and automatic glucose monitoring system (GlucoWatch Biographer). Member of the Executive Staff
  • Raychem
    Various
    Raychem Jun 1979 - Jun 1994
    Developed products based on specialty materials, primarily polymers, for the following industries: Electronics, aerospace, high voltage transmission, telecom, temperature maintenance, corrosion protection , wire and cable, and automotive.
    View

Pravin Soni Skills

Medical Devices Fda Product Development Pharmaceutical Industry R&d Gmp Project Management Biotechnology Commercialization Intellectual Property Clinical Development Clinical Trials Regulations Quality System Strategy Regulatory Affairs Technology Transfer Validation Drug Discovery Drug Delivery Formulation Start Ups Product Management Chemistry Biopharmaceuticals Pharmaceutics Life Sciences Manufacturing Design Control Capa Drug Development Process Simulation 21 Cfr Part 11 Regulatory Submissions Polymers V&v Lifesciences Iso 13485 Change Control Glp Characterization Cro

Pravin Soni Education Details

Frequently Asked Questions about Pravin Soni

What company does Pravin Soni work for?

Pravin Soni works for Pharmacro, Llc

What is Pravin Soni's role at the current company?

Pravin Soni's current role is President at PharmaCRO, LLC.

What is Pravin Soni's email address?

Pravin Soni's email address is pr****@****cro.com

What is Pravin Soni's direct phone number?

Pravin Soni's direct phone number is (650)-944*****

What schools did Pravin Soni attend?

Pravin Soni attended Case Western Reserve University.

What skills is Pravin Soni known for?

Pravin Soni has skills like Medical Devices, Fda, Product Development, Pharmaceutical Industry, R&d, Gmp, Project Management, Biotechnology, Commercialization, Intellectual Property, Clinical Development, Clinical Trials.

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