Medwisdom

Are You Looking For Experts In Submission?

At Medwisdom Lifescience  we recognises that a regulatory submission is a means to an end, and not an end in itself. Partner with us for seamless process of regulatory submission and approval.

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    Regulatory Submission Services

    In highly regulated pharmaceutical industry, ensuring seamless regulatory submission is significant for securing timely product registration in local or global market. At Medwisdom Lifescience, we provide smooth and reliable regulatory submission services with full compliance of product as per specific region regulatory authorities requirements, so that your product meets global regulatory framework and reach the market faster.
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    Regulatory Submission

    Your Partner In Regulatory Excellence

    We brings profound expertise, in depth regulatory affairs knowledge, regulatory strategy, and innovative approach at every stage of regulatory submission process, offering wife range of services that are designed to overcome challenges, simplify complexities, and ensure timely products approval. Here’s what we are best at:

    Global Regulatory Submissions

    Solving the complex challenges of regulatory compliance of specific regulatory authorities across the world like EMA, FDA, MHRA, and CDSCO. We are specialized in addressing these complexities to ensure your product reaches market efficiently.

    Regulatory Compliance

    We ensure that regulatory submission meets accurate specifications of specific regulatory body along with the technical documents, dossier formatting, and validation requirement.

    Accelerated Approvals & Query Response

    With precise documents and following regulatory pathway like EMA, CDSCO expedite, and FDA fast-track review process, we try to make your product reaches market faster. Our experts team review the queries from ministry and provide justification and response to queries on time, minimizing any delay.

    Regulatory Submission Process With Us

    The regulatory submission process involves series of steps, to ensure your product meets regulatory framework along with the applicable rules and regulations. Below are some major steps that are followed to execute regulatory submission process.

    Step 1

    Preparation of Documents: Crafting of technical documents and collection of data together such as safety, quality, and efficacy data and compiling it together to make one common technical document (CTD) or Electronic Common Technical Document (eCTD).

    Step 2

    Review for Compliance: Review of compiled data to evaluate the compliance of product data with respect to specific regulatory guidelines for effective regulatory submission.

    Step 3

    Submission to Regulatory Authority: Uploading or publishing of regulatory dossier (CTD or eCTD) as per the designated protocol from regulatory authority for efficient processing.

    Step 4

    Response to Queries: Addressing the queries raised by the authority effectively, to avoid any delays or rejections.

    Why Choose Us

    We are leading regulatory affairs consultant offering wife range of services for pharmaceuticals, medical device, cosmetics, and many more areas. We follows country specific regulatory framework that shows our commitment to quality and regulatory compliance across the globe. Some of our expertise includes:

    Global Reach

    Expertise in global regulatory submissions, ensuring your product compliance across domestic and international market.

    Rich Experience

    A team of experts having 20+ years of experience and in depth knowledge of global regulatory requirements for regulatory submission.

    Extensive Services

    From initial dossier preparation to final product submissions, we covers whole lifecycle management process.

    What Our Clients Think About Us

    Biobee General Manager

    As a General Manager, I highly recommend MedWisdom LifeScience Regulatory Services. Their expertise in navigating medical device regulations has been invaluable to our operations.

    imperial Lifesciences Head Regulatory Affairs

    Company services are excellent for CTD compliance and medical devices. Their expert team offers tailored solutions and efficient support. Highly recommended!

    Genes2me Director

    MedWisdom LifeScience Regulatory Services is a top choice for medical device companies. Their expert team offers tailored solutions to navigate complex regulations, ensuring compliance and efficient approvals. Professional and reliable, they are an invaluable partner in the regulatory process.

    Frequently Asked Questions

    Regulatory submission is the process of submitting technical and legal documents along with whole product data to regulatory authorities like (FDA, EMA, or MHRA) for seeking product approval and registration in different countries around the world. Regulatory submission ensure product must complies with quality, safety, and efficacy standard prior to its launch in market.

    The time for approval rely on the  nature of product and regulatory authorities, for example New Drug Application (NDA) usually takes 6-10 months. Abbreviated New Drug Application (ANDA) takes around 10 to 16 months for approval.

    CTD dossier includes five modules, each having specific data and information of product.

    • Module 1: Regional and administrative information.
    • Module 2: Summary of Module 3,4, & 5.
    • Module 3: Quality data of product.
    • Module 4: Non clinical data of product.
    • Module 5: Clinical data of product.

    eCTD submission provides a global regulatory framework, regional regulatory authorities have specific requirements. Examples includes:

    • USFDA: Requires labeling and compliance with PDUFA fees.
    • EMA: Mandates centralized procedure for many submissions.
    • PDMA: It has some additional validation criteria.
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