Medwisdom

Are You Looking For Regulatory Affairs Services?

  Reach out to Medwisdom Lifescience for expert support, with our in-depth knowledge and experience, we help you with regulatory compliance of your products for both domestic and international markets.

    Who We Are

    Global Regulatory Solutions

    At Medwisdom Lifescience Pvt Ltd, we specialize in providing comprehensive regulatory solutions for Pharmaceuticals, Nutraceuticals, Medical Devices, Cosmetics, Herbals, and Food Products. Our regulatory affairs services are designed to maximize your chances of success in both regulatory strategy and license submissions, ensuring that your products achieve market approval efficiently.

    Our team of highly qualified and experienced professionals will help you meet global regulatory compliance standards. We offer a wide range of global regulatory services, including GAP Analysis, Due Diligence, Technical Dossier Preparation, Technology Transfer, Intellectual Property protection, Company Registration, Medical Device Compliance, and Training. We also conduct GXP Audits and facilitate Import/Export processes to ensure seamless market entry.

    At Medwisdom Lifescience, our goal is to provide you with a smooth and successful path to market, leveraging our expertise in regulatory solutions for Pharmaceuticals and Medical Devices. Trust us to help you navigate the complexities of regulatory compliance with confidence, and experience the difference that our regulatory affairs services can make for your business. Reach out today to explore how we can support your journey to compliance and success!

    Our Services

    Consulting

    Personalized guidance for global regulatory solutions effortlessly.
    Personalized guidance for global regulatory solutions effortlessly.
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    Regulatory Strategy

    Smart planning and execution to make sure your products meet all regulatory requirements.
    Smart planning and execution to make sure your products meet all regulatory requirements.
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    Product Development

    Support in bringing innovative products to market while adhering to regulations.
    Support in bringing innovative products to market while adhering to regulations.
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    Documentation

    Clear and precise documents that simplify the submission process.
    Clear and precise documents that simplify the submission process.
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    Medical Writing

    Professional and scientific writing for clinical study reports and regulatory submissions.
    Professional and scientific writing for clinical study reports and regulatory submissions.
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    Submission

    Expert preparation and submission of applications to secure quick approvals.
    Expert preparation and submission of applications to secure quick approvals.
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    Post Approval

    Assistance in managing changes after approval, keeping compliance of your products and medical devices.
    Assistance in managing changes after approval, keeping compliance of your products and medical devices.
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    Medical Device

    Medical device regulatory services​ on time with expert support.
    Medical device regulatory services​ on time with expert support.
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    Due Diligence

    Medical device regulatory services​ on time with expert support.
    Medical device regulatory services​ on time with expert support.
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    Auditing (GxP)

    Comprehensive review and inspection to ensure compliance with Good Practice standards.
    Comprehensive review and inspection to ensure compliance with Good Practice standards.
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    Pharmacovigilance

    Continuous safety monitoring of your pharmaceutical products to protect patients and meet regulatory expectations.
    Continuous safety monitoring of your pharmaceutical products to protect patients and meet regulatory expectations.
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    Seamless Regulatory Submissions and Timely Approvals with Medwisdom Lifescience

    We guide our clients through every stage of the product approval. From document preparation and review to regulatory submission, we ensure complete compliance to country-specific guidelines. Our focus on regulatory accuracy, facilitate timely market entry and successful commercialization of product across diverse regions.

    Years Experience
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    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.

    Why Choose Us

    Regulatory Experts

    Our experts team specializes in regulatory affairs services to guide you through each and every step. Our pharmaceutical regulatory services are designed to simplify approvals and support your product lifecycle journey.

    Global Reach

     We provide global regulatory solutions to help you meet compliance internationally. Whether its new registration or seeking to maintain existing approvals, our global reach equips you with the knowledge that thrives you success.

    Medical Device Specialists

    We offer timely medical device regulatory services to ensure fast approvals. We provide end-to-end support, for test license, manufacturing license for (Class A to B)), and import license for your medical device.

    End-to-End Regulatory Affairs Solution For Domestic And International Markets

    Medwisdom Lifescience is your one stop global regulatory solution for guiding you through the complex world of Healthcare Compliance, Regulations, Medical Device, and Clinical Trials.

    Industrial Focus

    Pharmaceuticals

    Comprehensive regulatory affairs services for pharmaceutical products with quality and safety compliance.

    Medical Device

    Medical Device

    Registration for medical devices used in diagnosis, treatment, or monitoring (e.g., surgical instruments, diagnostic kits).

    Cosmaceuticals

    Cosmeceuticals

    Our consultancy specializes in global regulations services, including EU Regulation 1223/2009, U.S. FDA CFR Title 21, ASEAN Cosmetic Directive, and GCC GSO Standards.

    Our Trusted Partners

    Frequently Asked Questions

    Regulatory affairs services for pharmaceuticals are Dossier Preparation: CTD (Common Technical Document) or eCTD submissions, Clinical Trial Applications: Preparing and submitting INDs (Investigational New Drug, Marketing Authorization Applications (MAA), Post-Approval (Lifecycle Management), Pharmacovigilance Compliance, and Global Market Approvals: Meeting country-specific requirements for the USA, Europe, ASEAN, MENA, CIS, LATAM, etc.

    Regulatory solution providers guide and support pharmaceutical and medical device companies comply with global regulations by their expertise in product approvals, documentation, and lifecycle management.

    We offer dossier preparation (CTD/eCTD) service, clinical study report preparation and review, marketing authorization application (MAA), regulatory audit and inspection, pharmacovigilance, and post approval changes.

    We simplify the submission and approval process of pharmaceutical products with country specific regulatory requirements, helping companies to achieve faster and cost-effective approvals globally.

    Yes, we will assist you in ensuring all your documents meet regulatory standards, avoiding any delays and queries.

    Yes, we are specialized in medical device registration and obtaining test license, manufacturing license, and import license for your medical device, so far we have secured more than 2000 licenses for various medical devices.

    At Medwisdom Lifescience, we provide end to end support and hassle free experience to our clients, we have a team of industrial experts having more than 20 years of experience in regulatory compliance and successful approvals.

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