Regulatory Affairs Due Diligence - PowerPoint PPT Presentation

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Regulatory Affairs Due Diligence

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The field of regulatory affairs due diligence encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a medicinal product. Knors Pharma regulatory affairs due diligence work on behalf of pharmaceutical companies to compile information about medicinal products and present it in the form the authorities require. – PowerPoint PPT presentation

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Title: Regulatory Affairs Due Diligence


1
Due Diligence in Pharmaceutical Industry
2
Due diligence in Pharmaceutical Industry is the
thorough review and assessment of a potential
asset to determine the assets viability
(unknowns, benefits, and risks).  Due diligence
involves a detailed review of available data,
relevant regulations, and Literature to guide
informed licensing decisions and negotiations.
 As the pharmaceutical industry reaches record
numbers of acquisitions in recent years, the
challenges of acquiring assets are sure to be
present.
3
Why Choose Knors Pharma Solutions for Regulatory
Due Diligence in Pharmaceutical Industry ?
  • Help identifying Project Engineering Consultants
    for the new RD facility
  • Support identifying a right partner for your
    requirements of Formulation Development including
    parenteral.
  • Guidance for Contract Manufacturing and RD space
    for Pharmaceuticals
  • Evaluate process parameters for manufacturing
    from a compliance perspective.

4
Regulatory Affairs Due Diligence
  • Knors Pharma approach to regulatory affairs
    due diligence is to match regulatory expertise
    with scientific, clinical, nonclinical, and
    overall drug development expertise to support
    marketing approval and market acceptance.
  • Knors Pharma team of regulatory affairs
    professionals understand the statutes, key
    regulatory opinions, and procedures that make for
    successful interactions with regulatory
    authorities like the FDA. However, we also
    realize that this expertise is not enough.
    Equally important is the ability to generate
    well-written and succinct arguments that are
    grounded in proven scientific, regulatory, and
    overall drug development principles.

5
CONTACT US
www.knorspharma.com
91- 9878880408, 0162-351544
knorspharma_at_gmail.com
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