Technical Writing Services
Partners LLC: Biomedical Consulting

LSP’s principals are experts in written and oral presentation. They have published in prestigious peer-reviewed academic and medical journals, and have presented at numerous scientific meetings. They have authored regulatory submissions leading to more than 20 new product approvals, and prepared submissions for the US FDA and also for European and Asian regulatory agencies. LSP’s principals have been reviewers for academic monographs and for more than a dozen well-regarded journals. A few examples of the kinds of projects they can help you with are:

• Manuscripts for publication

• Meeting abstracts and PowerPoint^®1 presentations

• Clinical protocols, investigator’s brochures, package inserts and supporting documentation

• Regulatory documents for drug and device submissions to US and foreign regulatory agencies, including

• IND applications and submissions for drug approval (PLA, BLA, NDA, ANDA)

• Orphan Drug Applications

• Drug Master Files

• Safety reports

• Responses to questions and deficiency observations from regulatory agencies

• Device operation manuals

• Product monographs

• Content and graphics for presentations to regulatory agencies
  
   

 ¹PowerPoint^® is a registered trademark of the Microsoft Corporation