Need professional writing help?
Contact us for a free consultation. Whether you need help with technical writing or medical and regulatory writing, we have the expertise to help you meet your goals.
MEDICAL & REGULATORY WRITING
We have planned and prepared more than a dozen biologics license applications (BLAs), new drug applications (NDAs), major investigational new drug (IND) / clinical trial applications, and ANDAs for more than 25 different products. We have decades of combined experience in pharmaceutical/biologic development and contributing to global regulatory strategy for successful product registration and lifecycle management. This includes specialized international regulatory (FDA/EMA/PMDA/ICH) writing for medicine and medical devices, especially INDs, NDAs and their various components including IBs and all essential documents.
- IND, NDA, and BLA Submissions
- IBs, CSRs, and Protocols
- Module 2 and Module 5 Documents
- DSURs and Annual Reports
- Publications and Posters
- Other Clinical Trial Documents
WHY CHOOSE US
Fast Turnaround
Have a tight deadline? Not a problem. We have writers on stand-by ready for rapid response service. And don’t worry: speed doesn’t come at the expense of quality.
Quality Work
All our team members are high-qualified, educated and skilled writers. We take pride in producing quality, error-free documents.
Competitive Rates
Our team is small and we all work from home offices, keeping our overhead low and our costs down. Savings we can pass to you!
Best Talent
Top talent is rare and valuable. That’s why our founder hand-picked her best colleagues along the way to join our team.
REGULATORY DOCUMENT EXPERIENCE
Additional experience includes CMC data and write up, PK/PD breakdown and description, clinical protocols, briefing documents, CSRs, SSEDs and other formatted reports. Familiar with CTD/eCTD submission requirements, as well as some specialized European filings such as QRDs and CERs. R&D work has included laboratory protocols, patent disclosures, user manuals, interpretation guides, package inserts and all design V&V reports and protocols including template design. Experienced at writing and editing for scientific and medical research. Clinical medical writing experience has also included peer-reviewed manuscripts, monographs, reports, proposals, white papers, policy documents, dissertations/theses, abstracts, posters and feature articles.
TECHNICAL WRITING
We offer case studies, white papers, and articles for technology company websites and trade publications. Our experience and expertise include interviewing businesses about how the client’s solutions are creating better business outcomes as well as conducting extensive secondary research of products and solutions employed. Clients include HP, Symantec, IBM, and Dell.
We plan and author quality technical documentation. Our experience includes online Knowledge Base repositories of strategic, best practices articles; training materials; and contextual help for B2B, SaaS products. We interview software engineers, client services reps, and other subject matter experts as well as conduct extensive secondary research to write thorough yet succinct articles for end-users. Distilling technical jargon to easily digestible, insightful directions for end-users and fitting all of the disparate elements together in a logical way is what we do best.
Our experience in planning and writing tutorials and online training materials for employees and end users is extensive. We have authored training documentation for employees, written help documentation for internal proprietary software solutions, and documented processes for rapid, iterative optimization.
Our experience and expertise cover API guides (including specifications), software user guides, and equipment manuals. We know what Java, .NET, REST, and Python developers need. Our guides are clear and concise, telling users how to complete tasks they want to do with your software. We offer clear, accurate, numbered steps for operating machines and devices.
Phone:
(602) 284-4688
Address:
Headquarters in San Diego (Home Office)