Crafting clarity from complexity, our Medical Writing team delivers regulatory-compliant documents with the precision and expertise your trial demands. Led by Pharm.D. and Ph.D. professionals, we ensure that every deliverable – from study reports to regulatory submissions – meets the highest standards. Our specialized knowledge and commitment to accuracy support each stage of the drug development process, helping you navigate the regulatory landscape with confidence.
01.
Clinical Study Reports (CSRs)
Our medical writers develop comprehensive CSRs that accurately document study findings, following ICH guidelines to ensure clarity and compliance for regulatory review.
02.
Investigator Brochure Compilation & Updates
We compile and regularly update Investigator Brochures, providing essential information on investigational products to support safe and effective study conduct.
03.
IND & NDA Development
CRC supports Investigational New Drug (IND) and New Drug Application (NDA) development, preparing detailed, compliant submissions that facilitate regulatory review and approval.
04.
Manuscripts & Abstracts
Our team collaborates with your scientists to craft high-quality manuscripts and abstracts that showcase study results, supporting publication in peer-reviewed journals and enhancing scientific communication.
05.
Full ICH-Compliant Reports
We prepare full ICH-compliant reports to meet the technical requirements for the registration of pharmaceuticals, ensuring that all documents adhere to the latest standards set by the International Conference on Harmonisation.
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If you need any assistance, please feel free to contact us.
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200 Central Ave, Ste. 1200
St. Petersburg, Florida 33701
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