DRUG REGISTRATION SERVICES

Content Creation

Medical writing

Protocols for new drug Phase I-IV and re-evaluation study protol for post-marketing drug.

Other clinical study materials (Investigator's Brochure, Informed Consent Form, Case Report Form).

Clinical study report.

Searching the literature related to clincial study and summary writing.

CMC compilation and writing

The registration information compilation and organization staff have been engaged in information compilation for over ten years, familiar with the Chinese registration information writing format and regulatory requirements and have abundant practical experience. According to customer needs, they can assist in sorting out experimental data for various stages, write summary and relevant tables, organize experts to conduct pre-review and feasibility assessment of the compiled materials, and further improve the declaration materials according to the evaluation results.  

Drug Registration Services

Drug registration

IND, NDA, ANDA, DMF filling, Drug Substances, Excipients, Drug Packing Materials filing, BE filling in China, USA and Europe.

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Advantages ADVANTAGES

21 Years of Experience

Willingjet has over two decades of experience providing translation of media services to life science industry. Our team of professional linguists and experts has a deep understanding of the regulatory requirements, technical terminology, and cultural nuances necessary for successful medical translations.

Quality-Oriented

We are committed to delivering high-quality translations that meet the highest standards of accuracy, cultural appropriateness, and regulatory compliance. Our ISO 9001, ISO 17100 and ISO 13485 certifications demonstrate our commitment to quality management and continuous improvement.

Professional Team

Our team consists of highly qualified linguists and subject matter experts. All of our translators are native speakers of the target language and have a deep understanding of the cultural and linguistic nuances required for successful medical translations.

Always On-Time

We understand that deadlines are critical in any industry, which is why we prioritize on-time delivery. Our efficient project management processes, coupled with our experienced team, ensures that we deliver translations on time, every time.

Data Security

At Willingjet, we take data security very seriously. We use the latest encryption and security protocols to protect our clients' confidential information, and we have strict internal policies and procedures in place to ensure that all data is handled with the utmost care and confidentiality.

Cost-Competitive

We understand that cost is an important factor today, which is why we offer cost-competitive solutions without compromising on quality. We work with our clients to develop customized solutions that meet their budget and timeline requirements.

As one of content management providers, we can offer professional content manager service for clients, if you have needs, please contact us.

If you want to know more translation of press release and multicultural interpreter services, please visit our website.

Willingjet provides complete multilingual localization and translation solutions for the pharmaceutical industry, streamlining translation, testing, and multilingual desktop publishing. Our cutting-edge translation platform and expert native translators make the localization process simple and affordable for our clients. At Willingjet, we are dedicated to providing high-quality language solutions that meet the needs of our clients, no matter where they are in the world.