A case study outlining Artixio’s Regulatory Support for a Chinese
Pharmaceutical Manufacturer in Mexico.
Problem Statement
A Chinese Pharmaceutical Manufacturer, with a portfolio of generic drugs approved in various countries, was looking to expand its market presence to Mexico. However, the company faced significant challenges:
Lack of Local Presence: The company had no existing presence or experience in the Mexican market.
Regulatory Hurdles: The company was unfamiliar with the local regulations and the process of drug registration in Mexico.
The manufacturer needed an experienced partner to support their end-to-end regulatory requirements.
The Artixio Solution: End to End Regulatory Support for Pharmaceutical in Mexico
Artixio, with its deep expertise in global regulatory affairs, stepped in to provide comprehensive support to the Chinese Pharmaceutical Manufacturer. The solution provided by Artixio included:
Document Review: Artixio reviewed the translated English documents of the products that were already approved in other countries. This ensured that the information was accurate and complied with Mexican regulations.
Gap Analysis: Artixio conducted a thorough gap analysis to identify any missing information or discrepancies that could potentially delay the registration process.
Pre-submission Consultation with COFEPRIS: Prior to submission, Artixio consulted with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), the regulatory authority in Mexico. This helped in understanding the expectations and requirements of COFEPRIS.
Preparation and Submission of Dossier to COFEPRIS: Artixio prepared a comprehensive dossier as per COFEPRIS guidelines and submitted it for review.
Response to Queries: Artixio promptly responded to all queries raised by COFEPRIS during the review process to ensure a smooth approval process.
Marketing Registration Holder Services: After obtaining approval, Artixio provided Marketing Registration Holder Services, enabling the client to market their generic drug in Mexico.
Outcome
With Artixio’s support, the Chinese Pharmaceutical Manufacturer successfully registered their generic drug in Mexico. The entire project was completed in about 18 months, allowing the manufacturer to quickly establish a presence in the Mexican market and start serving the healthcare needs of the Mexican population. This case study exemplifies Artixio’s commitment to helping pharmaceutical companies navigate complex regulatory landscapes and achieve their business objectives.
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