In the 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.
We ensure your product meets the global regulatory framework and reaches the market faster. Our team brings profound expertise, in-depth regulatory affairs knowledge, and an innovative approach at every stage of the regulatory submission process.
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We offer a wide range of services designed to overcome challenges, simplify complexities, and ensure timely product approval — here's what we are best at:
Solving the complex challenges of regulatory compliance across the world including EMA, FDA, MHRA, and CDSCO to ensure your product reaches market efficiently
We ensure regulatory submissions meet accurate specifications of the specific regulatory body along with technical documents, dossier formatting, and validation requirements
Following regulatory pathways like EMA, CDSCO expedite, and FDA fast-track review process to make your product reach market faster with timely query responses
The regulatory submission process involves a series of steps to ensure your product meets the regulatory framework along with applicable rules and regulations:
Crafting of technical documents and collection of data such as safety, quality, and efficacy data, then compiling it together to make one Common Technical Document (CTD) or Electronic Common Technical Document (eCTD).
Review of compiled data to evaluate the compliance of product data with respect to specific regulatory guidelines for effective regulatory submission and ensuring all standards are met before proceeding.
Uploading or publishing of regulatory dossier (CTD or eCTD) as per the designated protocol from the regulatory authority for efficient and compliant processing and timely review.
Addressing queries raised by the regulatory authority effectively and in a timely manner to avoid any delays or rejections, ensuring smooth and uninterrupted progress toward final product approval.
We are a leading regulatory affairs consultant offering a wide range of services for pharmaceuticals, medical devices, cosmetics, and many more areas:
Expertise in global regulatory submissions, ensuring your product compliance across domestic and international markets. We follow country-specific regulatory frameworks that reflect our commitment to quality and regulatory compliance across the globe.
A team of experts having 20+ years of experience and in-depth knowledge of global regulatory requirements for regulatory submission, ensuring every dossier meets the highest standard of accuracy and compliance.
From initial dossier preparation to final product submissions, we cover the entire lifecycle management process, saving your time and resources while ensuring accuracy and regulatory compliance at each stage.
Find answers to common questions about regulatory submission and our support services.
Contact UsRegulatory submission in the pharmaceutical industry refers to the process of compiling and submitting all required technical, clinical, and quality documentation to a regulatory authority for review and approval of a pharmaceutical product. This includes:
Medwisdom Lifescience provides end-to-end regulatory submission support to help your product reach the market efficiently and on time.
The timeline for product approval after regulatory submission varies depending on the regulatory authority, product type, and submission pathway. General timelines include:
Medwisdom Lifescience assists clients in utilizing expedited review pathways such as FDA Fast Track and EMA PRIME to minimize approval timelines wherever eligible.
A Common Technical Document (CTD) dossier is a standardized format for submitting pharmaceutical product data to regulatory authorities. It is organized into five modules:
Medwisdom Lifescience provides expert CTD and eCTD preparation services to ensure your dossier meets all regional regulatory requirements.
While the eCTD structure is globally harmonized under ICH guidelines, regional variations exist in Module 1 and submission requirements across different regulatory authorities:
Medwisdom Lifescience has expertise in preparing region-specific eCTD submissions tailored to the requirements of each regulatory authority.
