Regulatory Affairs Due Diligence

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Due Diligence in Pharmaceutical Industry
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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.
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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.

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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.

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