Who We Are
CSOFT Health Sciences, leaders in clinical trial localization, provides AI/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in eCOA documentation including linguistic validation and are capable of supporting CTD/eCTD submissions with the FDA, EMA, and NMPA. Our language and technology supported solutions help to improve patient diversity in clinical trials. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions.
Industries We Serve
We are dedicated to industry-standard knowledge and quality
Helping You Globalize the Right Way
CSOFT’s experienced and dedicated global regulatory submission specialists help companies comply with these demanding multilingual documentation requirements for submissions while providing the highest linguistic quality
We can help you attain the appropriate, accurate, and sustainable compliance required throughout the entire submission process. We ensure our clients receive the necessary certifications to successfully enter emerging markets.
Medical Translation with a Focus on Precision
Our translation solutions are intended for document types relating to every stage of product development life cycle.
Quality in translation is extremely important, but within the life sciences industry, incorrect translations could literally be life threatening. We use industry-standard processes, however, we also offer flexibility for each customer to allow for their companies’ success, no matter the process.
The Knowledge Vault
Stay in the know
For many years, CSOFT has been supporting the life science industries as they continue to grow. We are dedicated to providing the highest-quality services to our clients, while making sure they have access to different policies and up-to-date information. As a medical communications company, we are taking the initiative to promote and increase awareness in the science community and to every individual.
Carver Bio Plants Seed to Treat Viral Threats with CRISPR Cas13
With a distinct take on CRISPR technology, Carver Biosciences secured seed financing to support the development of RNA-targeting gene therapies aimed at RNA-based respiratory infectious diseases. The undisclosed financing will further the company’s development of...
Psilera Receives First Patent Allowance for Transdermal Patch Formulations
Psilera Inc., a biopharmaceutical company optimizing next-generation mental health treatments, announces the patent approval of N,N-dimethyltryptamine (DMT) and psilacetin (4-AcO-DMT and psilocybin-like prodrug) transdermal patch formulations. Transdermal application...
Sermonix Pharmaceuticals Announces Results of Phase 2 Study of Lasofoxifene vs. Fulvestrant in Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation
Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, announced results of its signal-seeking Evaluation of Lasofoxifene in ESR1...