Are You Looking For Regulatory Dossier Services?
At Medwisdom Lifescience, we provide consultancy services for overall regulatory submission and approval along with due diligence, connect with us to know more.
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Regulatory Dossier Services
We are specialized in delivering expert regulatory dossier services that simply the regulatory approval process for your pharmaceutical products. Whether you are looking for pharmaceutical, cosmetics, medical device, or nutraceutical regulatory dossier preparation services, we are here to ensure regulatory compliance with global standards.
Our Regulatory Dossier Services
CTD Dossier Preparation
We provide precise and accurate CTD dossier preparation services for various regions like LATAM, AFRICA, and Europe. From Module 1 to Module 5, we ensure every detail is meticulously compiled to meet regulatory requirements of global regulatory authorities like FDA, EMA, CDSCO and many more.
Regulatory Submissions Services
Our regulatory submission services are designed in a way to meet country specific regulatory guidelines. We handle regulatory documents preparation, formatting, and submission, ensuring smooth pathway to pharmaceutical product approval in global market.
eCTD Filling Services
Stay ahead from your competitors with our eCTD filling services. We convert your dossier into compliance eCTD dossier format for smooth and effective regulatory punishing across various regulatory authorities, enhancing efficiency and tracking.
Drug Master File Services
In our Drug Master File Services, we creates high quality DMFs to support your Active Pharmaceutical Ingredients (API) registrations, proper manufacturing process, critical quality attributes and stability of active pharmaceutical ingredients helps to solidify your product registration, meeting complex regulatory requirements.
Pharmaceutical Regulatory Compliance
Regulatory compliance is the most challenging step in securing registration for pharmaceutical products. Our pharmaceutical regulatory compliance service ensures that our product meets global regulatory requirements, minimizing risk and potential delays in market approval.
Medical Device Regulatory Support
Timely approval and registration of medical device in India and global markets. From preparation of medical device documents like Plant Master File (PMF) to Device Master File (DMF), we ensure complete regulatory compliance for rapid market access of your medical device.
Industrial Recognition and Regulatory Excellence
Recognized Excellence
Over the years we have been instrumental in obtaining registration for 100+ products, varying from small molecules to biologics and vaccines. Our success is because of our commitment to quality and standard work ethics, separating us from others.
Advanced Publishing
Our team ensures accurate formatting, technical validation, and simple eCTD publishing. We manage regulatory submission across various regulatory authorities, including EMA, FDA, and GCC, ensuring region specific regulatory compliance.
Regulatory Intelligence
We have a team of regulatory experts with profound knowledge and experience in regulatory affairs submission. We provide proactive regulatory solutions for encountered challenges, our regulatory intelligence helps to mitigate potential risk.
Leading In Regulatory Compliance
Multidisciplinary Expertise
Professional skilled team in regulatory affairs, pharmacovigilance, medical device, cosmetics, and medical writing.
Global Network
Complete knowledge of local and International regulatory authorities including CDSCO, FDA, EMA, and MHRA.
Innovative Solutions
With advanced technology, provide efficient and compliance regulatory submission, reducing time to market.
Connect With Us For Regulatory Dossier Preparation Support
With in-depth knowledge of regulatory compliance for CTD, ACTD, and eCTD dossier preparation and submission, Medwisdom Lifescience is your trusted regulatory partner for global regulatory success. Reach out to us to know how our services can help your product journey from initial planning to registration in global markets.
What Our Clients Think About Us
Frequently Asked Questions
What formats of regulatory dossier do we provides?
Common format that we provides service includes Common Technical Documents (CTD), Electronic Common Technical Document (eCTD) , Asian Common Technical Document (ACTD), and country specific regulatory formats.
Do we provide support in both paper and electronic submission of regulatory dossier?
Yes, we provides regulatory support for both paper and electronic submission of regulatory dossier.
What is included in regulatory dossier preparation services?
Services usually includes:
- Gap analysis of existing data.
- Preparation of quality, safety and efficacy documents.
- Compilation of administrative data and application forms.
- Regulatory submissions to regulatory authorities.
What is the cost for preparing regulatory dossier?
The cost may vary depending on the type of product, regulatory region, and the scope of services you want.