Expert Regulatory Guidance

Reshaping the Future of Regulatory Success

Chart your regulatory success with precision. Our seasoned professionals, comprehensive research, and global proficiency redefine excellence in medical device regulatory affairs.

In choosing MAE Group, you’re not just selecting a regulatory partner; you’re choosing a team of dedicated professionals committed to ensuring your products reach the market with the necessary approvals. Experience the difference with us – where expertise, success, and client satisfaction converge for unparalleled regulatory support.

Darshan Bhaiya
Regulatory Affairs Specialist
Email: [email protected]
Phone: +1-603-505-0730

Connect with Darshan
Medical Device Regulations

Our Expertise​

We take pride in being the preferred choice for regulatory support, setting ourselves apart from the competition in several key ways.

Regulatory Advisors

Expert Regulatory Advisors

Our experts bring unparalleled expertise, ensuring submissions are handled by professionals who comprehend the regulatory intricacies with extensive experience.

Research Capabilities

Outstanding Research Capabilities

Mastery in effective research positions submissions strategically, staying compliant and aligned with evolving regulations for successful approvals.

Global Regulatory Submissions

Global Submission Expertise

With a remarkable 100% success rate, we navigate international regulatory landscapes, delivering approvals across diverse regions. Trust our precision and efficiency for regulatory excellence.

Key Insights

Numbers Speak

39.5%

of revenue growth highlights the remarkable success of the medical devices segment

33.5%

of the Regulatory Affairs market share is attributed to the oncology segment, driven by increasing global cancer cases.

9.32%

CAGR propels the global Regulatory Affairs market from USD 15.2 billion in 2022 to an anticipated USD 31 billion by 2030.

Key Features

Discover the top features that make our product unique and powerful.

Regulatory Strategy Development

Crafting tailored strategies aligning with your unique regulatory requirements. We ensure a streamlined pathway to market success through meticulous planning and compliance expertise.

Submission Management

Expertly navigating the submission process, optimizing documentation, and engaging with regulatory authorities for swift approvals. We ensure seamlessly efficient regulatory approval.

Post-Market Surveillance

Continued support for post-market activities, vigilance reporting, complaint handling, and comprehensive product lifecycle management. We prioritize compliance to uphold product integrity.

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Efficient Regulatory Pathways, Concept to Approval

Unlock a streamlined regulatory pathway with us. We streamline submissions, simplify compliance, and usher your products to market success. Optimize regulatory workflows, strategically allocate resources, and realize regulatory excellence. Your partner in shaping a future of regulatory success.

Latest Case Studies

Explore breakthroughs and success stories in our compelling success stories.

Address

250 Commercial Street, Suite 3007, Manchester, NH 03101

Call Us

+1 603-505-0730

Email Us

[email protected]

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