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INTERNATIONAL REGULATORY BUSINESS CONSULTANTS, L.L.C.

1-732-761-9400

 
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MISSION STATEMENT

Providing scientific and regulatory consultant services

to the global pharmaceutical,

dietary supplements and medical devices

and diagnostic products industries

 

 

Who We Are

 

 

Recognized health care manufacturing industry expert, with a blend of

 

- technical and business education

- expertise in global manufacturing, quality assurance, regulatory affairs

  and compliance

- technical expertise in pharmaceuticals, dietary supplements, 
  dosage forms and APIs, medical devices and

  diagnostic products and cosmetics

- strong written and verbal communication skills

- commitment to industry demonstrated through organizational
  and government regulatory contributions

- numerous presentations, publications and patents

 

 

KEY SUCCESS FACTORS

 

¨       Technical expertise as well as the necessary access to the FDA to implement successful audits and inspections, through full compliance, and approvals for product application regulatory approvals, ie, ANDAs/NDAs, DMFs.

 

¨       Lead global manufacturing and corporate initiatives.  Provide uniform operations in plants for product registrations worldwide, thus ensuring higher levels of compliance and reduced costs.  Organizing teams and establishing and implementing systems which produce results, as evidenced by successful company integrations from merger/acquisition activities.

 

¨       Management of multinational, multiplant operations to achieve corporate goals and global regulatory compliance – manufacturing, quality assurance and regulatory affairs and compliance.  Achieve worldwide product registrations and GMP compliance.

 

¨       Integrate the manufacturing and quality operations in a multinational organization into uniform and consistent quality standards and systems.

 

¨       Participation in a growing organization, to utilize my technical and business background and expertise toward developing the company's business and ability to supply quality products.

 

 

 

 

 

 

 

 

 

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509 Stillwells Corner Road, Suite E-4, Freehold, New Jersey 07728
ira.berry@irb-c.com
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