p
pearl_542

Pearl

@pearl_542
5,0(2)

ISO Consultant, FDA Compliance Specialist, MoCRA and QMS Expert

Stati Uniti
Inglese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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.... Continua a leggere

Competenze

p
pearl_542
Pearl
offline • 
Tempo di risposta medio: 2 ore

Consulta i miei servizi

Consulenze prodotti
I will handle fda 510k submission, US agent, mocra, fda registration and compliance,
5,0(2)
Gestione progetti
I will give iso 9001, 45001 , 14001, gmp, 22301 iso certification

Portfolio

Esperienza lavorativa

SOPG_Consulting

Independent Consultant

SOPG Consulting • Freelance

Dec 2025 - Present5 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

Risk_and Safety Plus

PrimeCert Consulting Group

Risk and Safety Plus • Freelance

May 2024 - Present2 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

FOOD_DEALS SUPPLY

Global Product Compliance Solutions

FOOD DEALS SUPPLY

May 2024 - Present2 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

2 Recensioni
5,0

(2)
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(0)
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Valutazione dettagliata
  • Livello di comunicazione del venditore
    5
  • Qualità della consegna
    5
  • Valore della consegna
    5
1-2 di 2 recensioni
Ordina per
Più rilevante
    M
    image-docs

    macleender

    Cliente abituale

    US

    Stati Uniti

    5

    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...

    Fino a 50 USD

    $

    3 giorni

    Tempo

    gig

    Consulenze prodotti

    Utile?
    No
    M
    image-docs

    macleender

    Cliente abituale

    US

    Stati Uniti

    5

    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.

    Fino a 50 USD

    $

    3 giorni

    Tempo

    gig

    Consulenze prodotti

    Utile?
    No