At Sapta Global, we recognize the critical role that regulatory compliance and innovation play in the healthcare and life sciences industry. Since 2018, we have been a trusted partner to leading global healthcare and pharmaceutical companies, providing specialized contractors to drive their regulatory affairs projects forward.

Our Expertise Includes:

Regulatory Affairs: Senior- and mid-level professionals experienced in navigating FDA submissions, EU MDR/IVDR, and global market registration processes.

Quality Assurance & Compliance: Skilled experts ensuring rigorous quality and safety standards are met across product lines and clinical operations.

Clinical Operations: Comprehensive support for clinical trial management, data monitoring, and regulatory study compliance.

Medical Affairs & Scientific Communications: Helping clients ensure scientific integrity and regulatory alignment in publications, medical education, and external communications.

Key Regulatory Areas:

FDA regulatory pathways (NDA, BLA, 510(k), PMA submissions)

EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

Global market authorization and registration

Post-market surveillance and compliance documentation

Why Choose Sapta Global?

Deep industry experience in healthcare and life sciences

Access to a pool of senior- and mid-level contractors with regulatory expertise

Flexible staffing solutions to meet evolving project needs

Commitment to compliance, quality, and innovation

At Sapta Global, we’re dedicated to helping healthcare and life sciences organizations navigate complex regulatory landscapes and bring their products to market with confidence.