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HOW WE CAN HELP YOU

FDA Regulation Consulting

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Don’t let that FDA Warning Letter throw you off – we can help. After 13 years of experience working with medical device and pharmaceutical companies in regulatory distress, we can get you back on track quickly.

  • Regulatory applications, mostly 510(K) pre-market notifications
  • Remediation, which we define as Quality Management System development and repair
  • Risk Management for both product safety and business

We are a trusted advisor who understands the headaches and hassles associated with everything from design and development through commercialization and post-market management.

We serve clients with the
following types of products:

Orthopedic <br>Medical Devices<
Orthopedic
Medical Devices
Cardiovascular <br>Medical Devices<
Cardiovascular
Medical Devices
Dental <br>Devices<
Dental
Devices
Physical <br>Therapy Devices<
Physical
Therapy Devices
Electronic <br>Medical Equipment<
Electronic
Medical Equipment
Opthalmic <br>Products<
Opthalmic
Products
Combination <br>Products<
Combination
Products
Dietary <br>Supplements<
Dietary
Supplements
Laboratories<
Laboratories
Contract <br>Manufacturers<
Contract
Manufacturers

We work closely with your business leaders and operate as a specialized extension of your cross functional business team to identify, remediate and transform costly business problems into highly-efficient and compliant operational and revenue generating machines.

We can equip you with the people, process and tools you need to eliminate the headaches, hassles and financial drain associated with non-compliance issues and their associated poorly performing business operations.

Read what some of our satisfied customers had to say after working with us.

To find out how we can help your business, contact us today for a free, no-obligation consultation