What services does Muhammad Saleem offer?

Muhammad Saleem offers QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Muhammad Saleem specialize in?

Muhammad Saleem specializes in Post Market and other FDA regulatory pathways for medical devices.

What is Muhammad Saleem's regulatory experience?

Muhammad Saleem has 10+ years of experience in FDA regulatory affairs.

Muhammad Saleem

Senior Quality Assurance Specialist Lead - Cell & Gene Therapy

A highly experienced Quality Assurance Lead with over 10 years in the pharmaceutical and biologics industry, specializing in GMP compliance and regulatory readiness for sterile manufacturing. Proven expertise in leading quality programs, directing CAPA and risk management (FMEA/RCA), and supervising batch release for complex products including cell & gene therapies and combination products. Adept ...

Experience: 10+ years

Expertise & Specializations

Regulatory Pathways

Post Market

Device Specialties

General SurgeryOther

Regions Served

Muhammad Saleem provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Asia-Pacific

Credentials & Recognition

Certifications

Six Sigma Green Belt & Black Belt Certification
University of Massachusetts Boston
2025

FPGEE

First Aid

CPR

Professional Experience

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

Post Market

Device Specialties

General SurgeryOther

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU, APAC
Background: 10+ years of regulatory experience.

Cruxi view

With over 10 years of specialized experience in the pharmaceutical and biologics sectors, Muhammad Saleem offers medtech companies profound expertise in Quality Assurance for complex and highly regulated products. His deep knowledge of GMP compliance, sterile manufacturing, and risk management (FMEA/RCA) is critical for organizations developing combination products, cell & gene therapies, or sterile medical devices. Having led quality programs and managed successful FDA/EMA interactions at major firms like Pfizer, he provides a proven framework for establishing robust Quality Management Systems. His expertise in sterilization validation, CAPA direction, and post-market support makes him an invaluable asset for ensuring audit readiness and maintaining the highest standards of product quality and regulatory compliance.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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