Specialized Regulatory Consulting Services

VioNova Solutions provides high-value advisory services through its worldwide base of top-tier expert consultants, who support the full process. Advisory services include product development and regulatory strategy, expert scientific and technical advice. VioNova Solutions team is comprised of highly knowledgeable experts with extensive experience preparing and submitting applications, including:

• 510(k) (Premarket Notification) and de novo submissions
• Premarket Approval (PMAs)
• FDA Pre Approvals Audits.
• Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance are part of an intelligent process.
• In addition to regulatory submissions, we can also help you prepare for and conduct meetings with the regulatory agencies.

VioNova Solutions is Your Trusted Compliance Expert!