Mandic & Co — Company History

Mandic & Co began as a specialized clinical trials monitoring consultancy, supporting early‑stage research teams and CROs across the United States and Europe. The company’s earliest engagements centered on oncology, partnering with sponsors conducting bowel and breast cancer studies. These foundational projects shaped the firm’s reputation for scientific rigor, operational precision, and unwavering commitment to participant safety.

2020–2023: Growth Through Clinical Excellence

As demand increased, Mandic & Co expanded its network of highly trained CRAs and strengthened its capabilities across all phases of clinical research. The team became known for its adaptability—supporting complex protocols, multicenter coordination, and high‑acuity therapeutic areas.
By 2023, Mandic & Co had established itself as a trusted partner for CROs seeking flexible, scalable monitoring support grounded in ICH‑GCP, GDPR/HIPAA, and modern eClinical systems.

2024: Expansion Into FDA 510(k) Regulatory Consulting

In 2024, Mandic & Co broadened its services to include FDA regulatory consulting, with a focus on 510(k) submissions and eSTAR compliance. This expansion was driven by increasing demand from medical device companies struggling with formatting issues, predicate justification, and AIQs that delayed clearance.

Mandic & Co quickly became a go‑to resource for device manufacturers navigating the complexities of Class II 510(k) submissions and early‑stage PMA planning. The firm’s strengths in documentation accuracy, risk assessment, and structured communication translated seamlessly into regulatory success for its clients.

2025–Present: Strategic M&A Advisory

Building on its analytical foundation and industry relationships, Mandic & Co launched a dedicated Mergers & Acquisitions advisory practice. The firm now represents both buyers and sellers across healthcare, manufacturing, distribution, and related sectors.

This expansion reflects Mandic & Co’s evolution from a specialized clinical consultancy into a multi‑disciplinary advisory firm offering:

• Clinical trials monitoring

• FDA 510(k) and regulatory submission support

• Full‑cycle M&A brokerage and strategic transaction guidance

Today, Mandic & Co operates nationally and remotely, serving clients across the U.S. and Europe. The company remains grounded in the same principles that defined its earliest oncology monitoring projects: precision, integrity, and a commitment to advancing science, compliance, and commercial success.