Regulatory Affairs Consulting
At Medwisdom Lifescience, we provide regulatory affairs consultation combined with regulatory strategy to simplify your path of product approval.
At Medwisdom Lifescience Pvt Ltd, we specialize in providing comprehensive regulatory solutions for Pharmaceuticals, Nutraceuticals, Medical Devices, Cosmetics
Our team of highly qualified and experienced professionals will help you meet global regulatory compliance standards.
At Medwisdom Lifescience, we provide regulatory affairs consultation combined with regulatory strategy to simplify your path of product approval.
Pharmacovigilance is essential for ensuring the safety, efficacy, and risk management of pharmaceutical products throughout their lifecycle. At Medwisdom Lifescience, we provide comprehensive pharmacovigilance services to help organizations maintain regulatory compliance while safeguarding patient health.
Regulatory compliance management is one of the critical step in development and approval of drugs, medical device and cosmetics. To overcome this challenge, effective regulatory strategy is used.
Medical devices require precise regulatory planning, documentation, and compliance management to enter and sustain global markets. Medwisdom Lifescience provides end-to-end regulatory support for medical device manufacturers, ensuring alignment with applicable regulatory frameworks and quality standards.
Comprehensive regulatory affairs services for pharmaceutical products with quality and safety compliance.
Registration for medical devices used in diagnosis, treatment, or monitoring (e.g., surgical instruments, diagnostic kits).
Our consultancy specializes in global regulations services, including EU Regulation 1223/2009, U.S.
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.
Get ServicesWe 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.
Get ServicesWe 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.
Get ServicesIn today’s rapidly evolving regulatory landscape, time is critical. Our experts help businesses stay compliant, competitive, and future-ready with tailored regulatory solutions that drive sustainable growth.
MedWisdom Lifescience provides regulatory expertise to help you navigate product approvals globally.
contact usWe offer end-to-end regulatory support including product registration, dossier preparation (CTD/eCTD), regulatory strategy, and submissions across pharmaceuticals, medical devices and cosmetics.
We serve pharmaceuticals, medical devices, nutraceuticals and cosmeceuticals, providing tailored regulatory solutions for each sector.
Timelines vary by product and region; simple registrations can take months while complex submissions may take a year or more. We provide an estimated timeline after assessing your product and target markets.
Yes — we have experience with regulatory authorities across Asia, Europe, North America and beyond to help secure approvals and maintain compliance globally.
We provide post-approval support including variations, renewals, pharmacovigilance assistance, market surveillance and regulatory maintenance activities.
As a General Manager, I highly recommend MedWisdom LifeScience Regulatory Services. Their expertise in navigating medical device regulations has been invaluable to our operations.
Company services are excellent for CTD compliance and medical devices. Their expert team offers tailored solutions and efficient support. Highly recommended!
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.
As a General Manager, I highly recommend MedWisdom LifeScience Regulatory Services. Their expertise in navigating medical device regulations has been invaluable to our operations.
Company services are excellent for CTD compliance and medical devices. Their expert team offers tailored solutions and efficient support. Highly recommended!
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.
