Scientific Rigor
Our documents are backed by data, evidence, and international best practices.
An experienced regulatory affairs professional with a deep understanding of the global medical device landscape. With a background in clinical research, regulatory strategy, and quality systems, Sachin established the company to fill a critical gap in the industry: clear, compliant, and credible documentation tailored to international regulations.
Regulatory Excellence – We stay ahead of changing regulations to keep your submissions on track.
Client-Centric Approach – Every project is customized to your product, timeline, and market needs.
Integrity and Trust – We build long-term partnerships through transparency, consistency, and quality work.
At PM Consultants Inc, our mission is to empower medical device companies with expert-driven documentation and consulting services that ensure compliance, accelerate approvals, and uphold patient safety.
Scientific Rigor
Our documents are backed by data, evidence, and international best practices.
Regulatory Excellence
We stay ahead of changing regulations to keep your submissions on track.
Client-Centric Approach
Every project is customized to your product, timeline, and market needs.
Integrity and Trust
We build long-term partnerships through transparency, consistency, and quality work.
At PM Consultants Inc., our strength lies in the collective expertise of our multidisciplinary team. We are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality system experts who share a common goal—to simplify the complex regulatory landscape for medical device companies.
global regulatory frameworks such as EU MDR, US FDA, ISO 13485, and ICH GCP. Whether it’s writing a Clinical Evaluation Report (CER), preparing a 510(k) submission, or developing a complete technical file, we approach every project with scientific rigour and regulatory precision.
We engaged PM Consultants Inc for EU MDR-compliant Clinical Evaluation Reports (CERs) across multiple products. Their ability to break down complex requirements into structured, regulator-ready documents was outstanding.
We needed urgent support to compile and update technical files for multiple Class IIb devices. The PM Consultants team quickly understood our needs, maintained full confidentiality,
Working with PM Consultants was a seamless experience. They helped us prepare our 510(k) submission with clear guidance, strong documentation, and strategic insights that helped us avoid unnecessary delays.
The team at PM Consultants Inc helped us with our Clinical Study Reports (CSR) and Investigator’s Brochure updates. They combine scientific accuracy with clear communication,
At PM Consultants we are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality
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