Muhammad Saleem
QA Lead with 10+ years in GMP compliance for biologics, cell/gene therapy & combo products. Expert in FDA/EMA readiness.
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 at managing CMOs, supporting IND/BLA submissions, and ensuring successful FDA/EMA interactions. Offers robust support for pharmaceutical medical devices, including sterilization validation and regulatory compliance. Combines deep technical knowledge with strong leadership to drive product quality and ensure inspection readiness for medical device and pharma clients.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) RTA Remediation / Refuse-to-Accept Fix
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Years Experience:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
general_surgery, other
Technology Types:
combo_product
Accepting New Clients:
Yes
