Looking for a trusted medical compliance consultant? Vicki Partridge offers over 30 years of experience in medical device regulatory affairs, guiding manufacturers through the complexities of Australian regulations. From pre-market submissions to post-market compliance, Vicki ensures your products meet necessary standards for successful market entry. With a proven track record and expertise in both medical devices and clinical trials, Vicki helps streamline your regulatory processes. Contact her today to learn how she can support your business!
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Design of medical equipment, drug enforcement and experts in regulatory matters. Before, during and after the completion of your product production make sure that you comply with the legislation, so that your approval process is effective and straight to the point.
Pharmaceutical Development Group (PDG) assists FDA regulated firms in the navigation of the U.S. submission, approval and post-marketing procedures across a variety of dosage forms and therapeutic areas. Our expertise spans prescription and nonprescription (OTC) drugs, both NDA and monograph, as well as devices. While PDG possesses the resources and experience to address large scale development projects, long-term regulatory strategies and complex non-clinical and clinical issues, we remain as nimble and responsive as the day of our founding. We can quickly and efficiently address unexpected emergencies. PDG maintains a posture of readiness to react and respond to your needs and regulatory urgencies 24 hours a day, 7 days a week. We recognize that you may receive an FDA Form 483 or Warning Letter, may be faced with the possibility of a recall, or have encountered some other sudden and urgent situation.
