Strategic Medical Writing Services


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Beckloff Associates, Inc., can add value to your regulatory submissions by understanding and interpreting the strategic and scientific aspects of your development program. The knowledgeable and experienced staff at Beckloff Associates, Inc., are able to align your data into approaches and formats that meet regulatory agency and potential licensor expectations. Beckloff Associates, Inc., can rapidly integrate and summarize dissimilar data into documents that will help you accelerate your development program and reduce time to proof-of-concept or market approval. In addition, through our in-house staff, we bring together the best technical writing team to prepare multi-disciplinary documents, including clinical, nonclinical and CMC information in an electronic-submission-ready process.

 

The Beckloff advantage:

  • Our team brings together combined strategic, technical, and writing expertise, collectively representing 100+ years of scientific and regulatory experience
  • Our team operates with detailed templates for standard documents, such as protocol synopses, study protocols, Clinical Study Reports, and Common Technical Document (CTD) formatted summaries that meet all ICH and FDA requirements
  • Our team uses "smart" project management approaches that emphasize effective communication, parallel processing, and pre-defined efficiencies that build quality into the writing process as documents are written
  • Our team functions as a reliable and seamless extension of your team to help you leverage your company's expertise and knowledge of your compounds in a way that is consistent with your corporate objectives


 

The Beckloff difference:

  • We are not a CRO but a technical and strategy-based group of scientists and technical writers
  • We are an experienced, industry-trained, hands-on group of writers who have been involved with all aspects of clinical drug development and numerous interfaces with regulatory agencies at all stages of development
  • We can leverage our regulatory experience to ensure that clear, concise, and meaningful documents are submitted to meet regulatory agency standards and expectations


 

The Beckloff high-quality, on-time deliverables:

  • Study protocol synopses and full protocols for all phases of development
  • Investigator's Brochures
  • Initial IND and IND Amendments in paper and eCTD format
  • IND Annual Reports and Periodic Safety Update Reports
  • Clinical Study Reports for all phases of development
  • Integrated Summary of Safety and Efficacy (ISS/ISE)
  • NDAs/BLAs in paper and eCTD formats