Quality and accuracy are paramount in pharmaceutical translation as they have a direct impact on the time to market of drugs and even the health of patients. As countries tighten their regulatory requirements for the approval of new drugs, an increasing number of international pharmaceutical companies are looking for professional multilingual solutions that can help them tackle the challenging approval process. EC Innovations enjoys longstanding partnerships with many of the world’s top pharmaceutical companies, and we are committed to providing customers with accurate and consistent translation services that strictly adhere to the quality and delivery requirements of the ISO 17100 and ISO 13485 standards.
Steps taken by China’s National Medical Products Administration (NMPA) to reform the regulatory system has allowed the acceptance of foreign clinical data and removed certain restrictions on the approval for imported drugs. This opens up opportunities for leading pharmaceutical companies around the world to pursue global expansion. As a reliable partner, EC Innovations has a proven track record of helping the biggest players in the pharmaceutical industry with their IND/NDA/BLA/ANDA registration applications.
Documents We Translate for Drug Launches
- IND/NDA/BLA/ANDA and other application-related materials (chemical drugs, biological products):
- Pharmaceutical research: Quality standards, production processes, process validation, method validation, stability studies, etc.
- Preclinical research: Pharmacological studies, pharmacodynamic studies, toxicology reports, etc.
- Clinical research: Clinical trial protocols, investigator’s brochure, clinical study reports, CRFs, ICFs, ethics approval letters, safety reports, clinical literature, etc.
- Pharmaceutical patent application materials, GMP certification materials
- Patient information leaflets (PILs), patient-reported outcomes (PROs)
- Summaries of product characteristics (SmPCs), labels and packages, website content, training and education documentation, etc.
Subject Matter Experts and Translation Teams in Specialized Areas of Expertise
EC Innovations’ Life Sciences Localization division is a business unit comprising more than 100 employees dedicated to the life sciences industry.
Our translation team consists primarily of native speakers of the target language, who serve in the following roles:
Subject matter experts (SME)
With a background in the field of life sciences and a wealth of experience and knowledge in clinical trial translation, SMEs provide support for terminology translation and maintenance, and answer questions raised by translators.
Outstanding translators
Identified through rigorous rating based on the Translation Quality Report (TQR), the same translators are assigned to the best of our ability, for projects on the same product line and for the same client.
Experienced proofreaders
With many years of clinical trial translation experience, our proofreaders are able to efficiently use cloud-based computer-assisted translation tools for real-time review and proofreading, providing feedback to translators in the shortest possible time.
Stringent reviewers
Reviewers have background knowledge of relevant clinical trials and they examine the translations through the eyes of the end-user, without referring to the content of the source document.
Quality assurance (QA) reviewers
The QA team samples 10% to 20% of the translations for individual quality review to identify possible quality issues.
Native reviewers or third-party reviewers
Upon request by the client, native-speaking or third-party reviewers will be brought in to further ensure translation quality.
Native language leads
Native language leads work closely with translator recruitment and project managers to assemble a custom professional translation team for each client.
Multilingual desktop publishing team
This team ensures that translated documents are compliant and can be published in the correct format.
ISO certification
We are one of the few language service providers in the world that holds ISO 9001, ISO 17100, ISO13485, ISO 27001, and ISO 18587 certifications. With over 20 years of industry experience and technical capabilities, we aim to help you reduce translation costs and improve efficiency by providing professional project processes, systematic project management solutions, and efficient quality control systems.
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.
Customer Success Story
Translation of documents for FDA New Drug Application (NDA)
The client, a well-known biopharmaceutical company in China, was struggling with poor translations that hindered their new drug registration process. Their internal reviewers were forced to deal with increased workload, as well as the pressure of meeting the FDA submission timeline. To ensure a seamless registration process for their new drug and reduce the burden on their internal reviewers, the client decided to engage the professional services of EC Innovations to meet their goals.
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