Welcome to Medpoint

Welcome to Medpoint, LLC, a leading domestic and international consulting firm for Quality Assurance, Regulatory and Clinical Affairs. We have over 50 of the most highly qualified consultants working all levels of projects in Medical Device, Biotech, and Pharmaceutical in over 90 countries.

Our clients span the spectrum from start-up to Fortune 20 and look to us for short-term or long-term expertise in the following areas:

  • FDA Guidance
  • CAPA’s
  • Quality System Regulations
  • IS0 13485
  • QMS Audits
  • European CE Marking
  • Technical Files
  • 510 (k)/IDE/PMA/ANDA/NDA Approvals
  • STED
  • Japan PAL
  • China SFDA
  • Sterilizations
  • Canadian Licenses
  • Internal and Supplier Audits
  • FDA Mock Audits
  • 483 & Warning Letter Responses
  • IVD
  • Biologics
  • Blood and Blood Products
  • Clinical Trial Strategy/Monitoring
  • ISO 14971
  • Validations
  • Design Control
  • Risk Analysis & Management
  • DHF Development
  • CMDCAS
  • GMP
  • Resolving Consent Decrees
  • Global Regulatory Strategies
  • Drug Listing, Registration, and Master Files

Medpoint Weblog

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U.S. Approves AstraZeneca Asthma Drug for COPD

Posted on March 11th, 2009

U.S. Approves AstraZeneca PLC (AZN) (JOBS) Asthma Drug for COPD
3/2/2009
SYMBICORT provides a new, fast-acting(1) combination treatment option for millions of Americans with debilitating lung disease
WILMINGTON, Del., Feb. 27 /PRNewswire-FirstCall/ — AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment [...]

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FDA Approves REPEL Adhesion Barrier

Posted on March 11th, 2009

 
FDA Approves SyntheMed, Inc. (SYMD.OB)’s REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
3/9/2009
ISELIN, N.J., March 9 /PRNewswire-FirstCall/ — SyntheMed, Inc. (OTC Bulletin Board: SYMD – News), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) [...]

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UNC vs. duke

Posted on February 11th, 2009

The nation’s best rivalry renews tonight in Durham, as the season’s first installment of Carolina-Duke takes place at Cameron Indoor Stadium. Oh, and it’s also a battle for first place in the Atlantic Coast Conference. 
GO Heels!

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World’s smallest heart pump saves lives

Posted on February 11th, 2009

A couple of months ago, Jerry White was referred to hospice care. Now he’s looking forward to going bass fishing and tinkering with old cars.
What made the difference? A new device that enabled doctors to open a blockage in the only remaining artery pumping blood to his heart.
Touted as “the world’s smallest heart pump” by [...]

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So sorry Duke fans!

Posted on February 5th, 2009

What a spanking last night was inflicted on the Duke men’s basketball team. As a Tarheel fan, my heart is broken…yeah right

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