Regulatory Representative Office: Pharma & Medical Device Registration

Welcome to our Medisyncglobal Regulatory Representative Office. We specialize in providing comprehensive regulatory support to pharmaceutical and medical device companies.

Overview of the regulatory representative office

Our team comprises seasoned professionals with extensive experience in regulatory affairs across various sectors of the healthcare industry. We have successfully guided numerous clients through the regulatory maze, resulting in timely approvals and market success.

We ensure your products meet all local and international regulatory requirements. Our services include maintaining product licenses and authorizations, ensuring continuous compliance with evolving regulations.

Our goal is to streamline your journey through the regulatory landscape, ensuring compliance and facilitating market access for your innovative healthcare products.

Regulatory Consulting and Strategy: Our team offers expert guidance on regulatory strategy, helping you navigate complex regulations and achieve compliance efficiently.
Product Registration and Submissions: We handle the entire registration process for pharmaceutical products and medical devices, ensuring timely and accurate submissions to regulatory authorities.
Regulatory Intelligence and Gap Analysis: Stay ahead of regulatory changes with our in-depth intelligence reports. We also identify gaps in your current dossiers and provide actionable recommendations for improvement.
Pre-market Consultation and Support: Our pre-market services include thorough evaluations and consultations to prepare your products for successful market entry.
Post-market Surveillance and Compliance: We offer ongoing support to maintain compliance post-approval, including monitoring, reporting, and addressing any regulatory issues that arise.
Quality Management System (QMS) Documentation and Audits: Our experts assist in setting up and maintaining QMS documentation and conduct internal audits to ensure adherence to Good Distribution Practices (GDP).
Certification Support for Good Distribution Practices (GDP): We provide comprehensive support for obtaining and maintaining GDP certification, ensuring the integrity and quality of your distribution processes.

Process and Methodology

We adopt a structured approach to regulatory support, tailored to meet the specific needs of each client. Our methodology includes

Initial Assessment

Conducting a comprehensive evaluation of your current regulatory status and needs.

Customized Planning

Developing a tailored regulatory strategy that aligns with your business objectives.

Implementation

Executing the regulatory plan with precision, leveraging our expertise and advanced tools.

Ongoing Support

Providing continuous support to address any regulatory challenges and ensure compliance throughout the product lifecycle.

If you have any enquiry, please do not hesitate to contact us..

Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management.

Leave us a message, and we will get back to you shortly.