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  • Regulatory Affairs consultancy& 3RD party audits
    Regulatory Affairs consultancy& 3RD party audits

    Regulatory Affairs consultancy services for the medical and pharmaceutical industries.

    The Regulatory Affairs team is a niche scientific and regulatory consulting group.

    We can do the following consultancy services:

    1. Technical documents of electronic Common Technical Document (eCTD) as per ICH guidelines;

    2. Highly recognized European regulatory affairs consulting services for CMC, quality, non-clinical, toxicology, clinical, and medicinal products.

    3. Support to help you succeed in all regulatory aspects of medicinal products in United States from development, registration through to commercialization.

    4. Also consultancy services on other countries, like Africa, South America and Asia.

    5. Specialized professional team on 3rd party audits, and we have stable auditors who can do English-speaking audit.