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Pearl
@pearl_542
ISO Consultant, FDA Compliance Specialist, MoCRA and QMS Expert
Vereinigte Staaten
Englisch
Über mich
Hi, I’m Pearl.
I specialize in ISO systems and FDA compliance, helping businesses become fully compliant and audit-ready without stress. With hands-on experience in ISO 9001, 14001, 45001 and FDA processes including MoCRA cosmetic registration, product listing, U.S. agent support, and labeling compliance, I provide audit-ready solutions built for real approvals. No guesswork, no templates, just accurate, structured compliance done right the first time.
I’ve worked with brands and manufacturers to handle everything from ISO implementation to FDA MoCRA registration and product listing.
Kompetenzen
Pearl
offline •
Durchschnittliche Antwortzeit: 2 Stunden
Meine Dienstleistungen
Produktberatung
I will handle fda 510k submission, US agent, mocra, fda registration and compliance,
Projektmanagement
I will give iso 9001, 45001 , 14001, gmp, 22301 iso certification
Portfolio
Arbeitserfahrung
Independent Consultant
SOPG Consulting • Freiberufler
Dec 2025 - Present • 5 mos
• Assisted businesses in building structured QMS frameworks aligned with ISO standards • Developed SOPs, policies, and compliance documentation for operational efficiency • Performed gap analysis and provided step-by-step implementation strategies • Supported audit preparation and documentation review for certification readiness
PrimeCert Consulting Group
Risk and Safety Plus • Freiberufler
May 2024 - Present • 2 yrs
• Led ISO 9001 and ISO 45001 implementation projects from gap analysis to full compliance • Conducted risk assessments and developed corrective action plans • Assisted clients during external audits and certification processes • Ensured compliance with international standards and continuous improvement practices
Global Product Compliance Solutions
FOOD DEALS SUPPLY
May 2024 - Present • 2 yrs
• Managed FDA cosmetic registrations under MoCRA, including facility registration and multi-product listings • Provided U.S. Agent support and handled regulatory communication requirements • Conducted ingredient and label compliance reviews aligned with FDA regulations • Assisted brands in achieving full import compliance before U.S. market entry
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macleender
Wiederkehrender Kunde
Vereinigte Staaten
Honestly, working with Pearl made the whole FDA process far less stressful than I expected. She helped me with my FDA registration, U.S. Agent service, and product compliance, and was very patient in explaining everything clearly along the way. Communication was easy, delivery was fast, and I genuinely...
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macleender
Wiederkehrender Kunde
Vereinigte Staaten
Second project with Pearl and again she delivered excellently. She handled my FDA cosmetic registration and MoCRA compliance smoothly, explained everything clearly, and made the process stress-free. Very professional and reliable. Highly recommended.
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