Extensive experience in bringing medical devices, pharmaceuticals, and combination products to market

Experience in Quality Assurance and Regulatory Affairs managing the product development lifecycle from concept through commercialization of medical devices, pharmaceuticals, and combination products. Thorough understanding of the regulatory requirements and expectations of worldwide regulatory health authorities gained through successful regulatory submissions. Successfully developed and executed quality and regulatory plans guiding teams and projects to meeting milestones. Have had the opportunity to work in R&D, Manufacturing, Clinical, Quality, and Regulatory roles in medical device and pharmaceutical companies acquiring a breadth of experience to help organizations navigate the challenges toward bringing products to market.

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The satisfied clients of QARA BioMed

About me, Mark Agostino

Seasoned, energetic Quality Assurance and Regulatory Affairs professional with 20+ years of experience in pharmaceuticals, medical devices, and combination devices.

  • Extensive experience in implementing quality systems to current industry standards and regulatory expectations for pharmaceutical and
    medical device organizations.
  • Managing the total product development lifecycle from concept in to commercialization.
  • Ensure production activities for existing products including technology transfers to multiple contract service providers are compliant to appropriate regulations.
  • Experience with 510k, PMA, NDA, MAA, IND, IDE regulatory submissions

Demonstrated ability to adapt effectively to the needs of the role and being successful in delivering results.

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Hello, this is Mark Agostino. How can I help you? Send me a message on WhatsApp.