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Skills

  • Review Writing
  • Regulatory Audits
  • Regulatory Operations
  • API Development
  • Compliance Consulting
  • Cosmetics Industry
  • Drafting
  • Gap Analysis
  • Health Sciences
  • Pharmaceuticals
  • Regulatory

Services

  • Regulatory affairs consultation

    $40/hr Starting at $100 Ongoing

    Dedicated Resource

    I offer full service by providing guidelines for submission of generics (ANDA) to the FDA, EMA, and MHRA. Dossiers drafting, review, and submission via ECTD to avoid RTR (refuse to review). Formatting...

    DraftingGap AnalysisRegulatory AuditsRegulatory OperationsReview Writing
  • Online or onsite compliance audit

    $40/hr Starting at $100 Ongoing

    Dedicated Resource

    I am specialize in conducting compliance audits within the pharmaceutical industry (APIs and excipients manufacturers). With a keen eye for detail, I meticulously review processes, documentation, and...

    API DevelopmentCompliance ConsultingPharmaceuticalsRegulatory AuditsReview Writing
  • I will register your cosmetics with FDA

    $25/hr Starting at $40 Ongoing

    Dedicated Resource

    Key Steps for Cosmetics Registration: Establishment Registration: Cosmetic manufacturers and distributors must first register their establishments with the FDA. This includes facilities where cosmetics...

    Cosmetics IndustryHealth SciencesRegulatoryRegulatory OperationsReview Writing

About

I, a distinguished organic chemist, hold a Ph.D. in Organic Chemistry from the Federal University of Sao Carlos, Brazil. My research focuses primarily on natural product synthesis and their biotransformation.

I have made significant contributions to the field of chemistry, with an impressive record of publications in renowned scientific journals. My work primarily revolves around designing and synthesizing novel compounds, showcasing my expertise in this domain.

With a diverse career, I have held key positions in regulatory affairs, including senior management roles. My responsibilities encompass Chemistry Manufacturing and Control (CMC), Electronic Technical Documents (E-CTD), and regulatory submissions to esteemed agencies such as the US-FDA, MHRA, and ANVISA. My dedication to regulatory compliance underscores my commitment to ensuring the safety and effectiveness of pharmaceutical products.

Beyond my professional accomplishments, I am a polyglot, proficient in English, Portuguese, Urdu/Hindi, and Pashto. My multilingual abilities have facilitated my global collaborations and enriched my contributions to the scientific community.

In essence, I am a respected figure in the realm of organic chemistry. I am renowned for my unwavering dedication to research, meticulous adherence to regulatory standards, and my ability to bridge the gap between scientific innovation and regulatory requisites within the pharmaceutical sector. My career is a testament to my passion for scientific exploration and my commitment to advancing our comprehension of organic chemistry and its practical applications.