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Regulatory Consulting

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Regulatory Affairs Consulting

The pharmaceutical industry is one of the utmost regulated industries globally composing of numerous different regulations.

Regulations change constantly and to remain up-to-date is a labor-intensive job. With Pharma Consulting as your reliant partner, you can rest assured that you get the latest information and the newest insights. Whether you only have one specific question or you need full Regulatory Affairs support, you can trust us.

Specific Services
Overall Market Strategy

We provide support in determining an effective overall market strategy (i.e. market approval, import, distribution, storage).

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Assessment

Review of all technical documentation from a regulatory perspective, i.e. instructions for use (IFU), FSCs, FGCs, risk management plans, and labeling.

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Regulations

Consulting on local directives. guidelines, and regulations.

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What We Offer

Regulatory Intelligence

Assembling, monitoring, and assessing the regulatory information from all sources.

Regulatory Submissions

Assembling, publishing, and submitting the registration applications to our local regulatory agency.

Postapproval Maintenance

Regulatory maintenance of marketing authorizations. Major and minor changes to approved applications.

Translations

Specialist translations of the product information texts.

Get in Touch

    Contact us on WhatsApp at 997556699 or by email at info@pharmaconsulting.pe and quote our regulatory consulting services in Peru.
    Over 15 years of experience will ensure you get the best guidance.