Are You Looking For Regulatory Affairs Services?
- Team of Industry Experts
- Expertise in Regulatory Submissions
- Clear and Effective Communication with Client
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
Regulatory Strategy
Product Development
Documentation
Medical Writing
Submission
Post Approval
Medical Device
Due Diligence
Auditing (GxP)
Pharmacovigilance
Regulatory Dossier
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.
What Our Clients Think About Us
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
Registration for medical devices used in diagnosis, treatment, or monitoring (e.g., surgical instruments, diagnostic kits).
Cosmeceuticals
Our Trusted Partners
Frequently Asked Questions
What are regulatory affairs services for pharmaceuticals?
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.
What does a regulatory solutions provider do?
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.
What pharmaceutical regulatory services do you offer?
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.
How can your global regulatory solutions benefit pharmaceutical companies?
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.
Do you provide regulatory compliance consulting services?
Yes, we will assist you in ensuring all your documents meet regulatory standards, avoiding any delays and queries.
Do you handle medical device regulatory services as well?
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.
Why should we choose Medwisdom regulatory affairs service providers?
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.