Regulatory Affairs

Product Evaluation

Product Review

  • In-depth Gap Analysis:
    Regucy reviews your proposed product claims and formulation, offering advice and guidance on potential impacts on product classification.

  • Strategic Guidance:
    Our experts provide insights to optimize your product for regulatory approval, ensuring a smooth pathway to market.

Product Submission

  • Efficient Paperwork:
    Regucy completes all required paperwork and submits your product application on your behalf.

  • Submission Review:
    We meticulously review the submission upon receiving the product classification to ensure accurate classification.

  • Collaborative Preparation:
    Working closely with you, we prepare the Regulatory Affairs (RA) license application, ensuring adherence to regulatory standards.

Product Launch Roadmap

  • Tailored Checklist:
    Based on your product's classification, Regucy creates a step-by-step checklist for the successful distribution of your product in your selected country.

  • Strategic Guidance:
    Our roadmap outlines critical steps and highlights common pitfalls, providing strategic guidance for a successful product launch.

Facility Registration & Listing (FEI)

Navigating FDA requirements involves technical validation and specific formats. Trust Regucy to streamline these processes and keep your facilities compliant:

  • Proper Facility Registration:
    We guide you through the proper registration process, ensuring compliance with FDA regulations for selling regulated products.

  • Listing Requirements:
    Our experts handle the listing process, ensuring that your products are correctly listed with the FDA.

  • Renewals and Annual Submissions:
    We manage the timely renewal of food facility registrations and the annual registration and listing for medical device or drug facilities.

Clinical Trail

Applying for Clinical Trials is a daunting yet necessary undertaking. With Regucy's extensive experience with Health Canada, FDA, and EMA, we simplify the complexity and ensure accurate paperwork submission. We work with you to:

  • Negotiate and Submit Clinical Trial Applications (CTAs to Health Canada & INDs to the US):
    Our experts facilitate the application process, ensuring accurate submission and negotiation for Health Canada CTAs and US INDs.

  • Review Bioavailability/Bioequivalence Study Reports:
    We review study reports and data analysis, ensuring compliance with Therapeutic Products Directorate (TPD) requirements.

Label Review

Ensuring label accuracy is crucial in meeting consumer demand for transparency. Regucy's specialists can help:

  • Meet Plain Language Labelling Requirements:
    We ensure your labels comply with Plain Language Labelling and readability standards.

  • Disclosure of Active Medicinal Ingredients:
    Our experts verify proper disclosure of active medicinal ingredients, aligning with Health Canada regulations.

  • Assessment of Label Compliance:
    We assess existing labels for compliance with current regulations, providing recommendations for updates.

  • Creation of New Labels:
    Working in line with your license, we create new labels to meet regulatory requirements.

  • Translation Services:
    We translate new labels into the French language, ensuring compliance with bilingual labeling standards.

Market Authorization Holder

Navigating the complexities of market authorization is simplified with Regucy serving as your dedicated Market Authorization Holder. Our services include:

  • Comprehensive Market Authorization:
    Entrust Regucy as your MAH to navigate the intricate process of obtaining and maintaining market authorization. We ensure strict compliance with regulatory requirements, allowing you to focus on your core business operations.

  • Renewals and Updates:
    Our commitment extends to managing renewals and updates on your behalf. Stay confident that your market authorization stays current and aligned with evolving regulatory standards.

Medical Translation

As borders blur and markets expand, ensuring your regulatory documents are accessible in multiple languages is paramount. Regucy's Multilingual Translation Services are designed to:

  • Bilingual Labeling Compliance:
    Guaranteeing compliance with bilingual labeling standards, especially essential for products in diverse markets.

  • Precision in Translation:
    Translating technical content with precision, maintaining the integrity of information across languages.

  • Cultural Nuances Consideration:
    Accounting for cultural nuances in translation, ensuring your documents resonate with diverse global audiences.

With Regucy's Technical Writing and Translation Services, step confidently into a realm where precision meets clarity, and regulatory compliance knows no language barriers.

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GxP Complaince