In an ever globalizing world, entry into emerging markets has become an indispensable strategy for Chinese pharmaceutical companies, but the process of completing local registration applications remains a challenge. EC Innovations’ drug registration application translation and consulting services help you complete the evaluation, translation, preparation, and review of registration application dossiers for emerging markets such as Southeast Asia, South America, and Belt and Road Initiative countries. With our assistance, you can overcome difficulties with local registration applications and achieve rapid entry into local markets.
Services
CTD file structure
&content verification
The accuracy and completeness of the structure and content of CTD files are important for ensuring the smooth progress of the registration application. We offer full verification of the content and structure of your CTD files and provide professional guidance to ensure that they meet local pharmaceutical regulatory requirements.
Compilation of complete sets of registration materials for Southeast Asia/South America/Belt and Road Initiative countries and regions
Different countries and regions have different registration and application requirements, and the materials required for submission also vary. We can provide you with translation, preparation, and review services for complete sets of registration dossiers for Southeast Asia, South America, and Belt and Road Initiative countries/regions, and ensure that your application dossiers are complete.
SMEs for registration-related translation work
Language translation is a critical part of the registration and application process. We have a professional SME (subject matter expert) team to ensure that our translations are accurate and comply with local regulations and pharmaceutical regulatory requirements.
Pharmaceutical Regulatory Success Stories
Registration Material Gap Analysis Report
Background
A Chinese pharmaceutical company had a product approved in China which was selling well. The company planned to export it to emerging markets in Southeast Asia, but market access risks regarding the pharmaceutical regulatory authorities in the region needed to be analyzed first.
The challenge
ECI was requested to compare the company’s existing CDE registration catalog (in Chinese) with ASEAN ACTD regulations and create a gap analysis report. The report aimed to allow company management to understand the gap between the existing Chinese registration materials and the ASEAN ACTD requirements, the completeness of the existing materials, and which additional content was required.
Solution
Experts with more than 10 years of experience in drug registration in the Southeast Asian market were arranged to conduct a full analysis of the Chinese registration catalog. Being conversant with ACTD regulations allowed the experts to check the completeness of each module in the existing data, carry out a thorough gap analysis, and provide detailed suggestions for additional materials.
Result
The project was successfully completed and a high-quality registration material gap analysis report was generated for the customer, providing a reliable basis upon which the customer’s management could formulate further market strategies.
CTD File Compilation
Background
A Chinese pharmaceutical company had a set of registration materials comprised of more than 100 documents for a vaccine they planned to submit to India (ECI had translated the materials into English and completed the formatting work). The customer requested ECI to organize these documents into a complete set of registration documents according to the CTD directory structure.
The challenge
ECI needed to clearly identify the specific contents of over 100 documents and their modules, accurately move each file into the corresponding folder, and name the files and folders based on knowledge of the directory rules of the CTD folder structure to produce a complete set of registration documents that comply with CTD format requirements.
Solution
An expert with 15 years of drug registration application experience who had a deep understanding of the CTD format was assigned to compile the documents.
Result:
The project was completed smoothly and we helped the customer organize a complete registration dossier in the CTD format within two days.
Compilation and Translation of Southeast Asian Registration Application Dossiers for a Chinese Biopharmaceutical Project
Background
A well-known Chinese pharmaceutical company planned to expand its business in Southeast Asia to meet the huge clinical demand for high-quality, affordable Chinese drugs in emerging Southeast Asian markets. This project was the first time a product of its class in mainland China entered Southeast Asia. The product had been launched in China and there was a set of Chinese registration dossiers. A set of English-language application dossiers was also available as the product had been submitted for registration in African countries. The customer requested ECI to compile a set of English application dossiers to meet the requirements of ASEAN ACTD by comparing, supplementing, and translating the two sets of existing materials.
The challenge
To compile a set of English application dossiers that met the registration requirements of Indonesia (ACTD) using a set of Chinese CDE registration dossiers from 2014 and a set of English application dossiers from 2018 (African country, similar to the CTD format). The project involved two languages and three different registration regulatory requirements. The original materials were also relatively old, with many updates required, including the process and stability requirements for the drug substance and drug product. An understanding of biopharmaceutical registration materials, knowledge of relevant national laws and regulations, and highly-accurate translations were nonnegotiable requirements.
Solution
Two experts with extensive experience in drug registration in emerging markets were arranged to review and compare the two existing versions of registration materials. By comparing the English application dossiers with the requirements of ACTD regulations, the incomplete and non-compliant parts of the English application dossiers were supplemented with corresponding information translated from the Chinese version. Finally, a complete set of English registration application dossiers that met the regulatory requirements of Southeast Asia was compiled. During the project, ECI’s pharmaceutical regulatory experts and project managers maintained close collaboration with the customer, organized regular meetings, and accurately identified and fulfilled the customer’s demands.
Result
The project was completed successfully and on time. A set of high-quality Indonesian biopharmaceutical registration materials was delivered to the customer. The product successfully obtained approval from the local pharmaceutical regulatory authority and was sold into this emerging market in Southeast Asia.
Information Security
We are deeply aware of the importance of confidentiality and do our utmost to ensure the security, confidentiality, and integrity of customer documents and communications.
- Project documents are protected by adhering to strict procedures and guidelines throughout the project process.
- All project personnel are required to sign a non-disclosure agreement.
- We have passed all customer security audits, including global audits by multinational corporations.
- We have achieved ISO 27001 information security management system certification.
- Multiple data encryption technologies are adopted when transmitting data.
- Reliable backup, disaster recovery, and data recovery mechanisms in place.
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