Grant and Technical Writing
Grants
Strategic development combined with writing expertise
Flexible approach tailored to each client Outline of development plan.
This service includes:
●Define attainable milestones
●Gantt chart
●Survey & recommend relevant calls for proposals
●Draft & submit pre-proposals, proposals and follow-up
●Assist with grant reporting obligations
Commercial considerations
Many grants take the form of a business plan, therefore the financial aspects must be reasonable and sound. Gsap can assist companies in the following areas:
●Budgeting – Gsap’s considerable experience interfacing with other service providers and can assist in estimating costs
●Match making – most clients out-source part of their development, Gsap can assist in
identifying suitable partners
● Cost of goods
●Forecasting
●Sales projections
●Competitive environment assessment
●Intellectual property considerations
●Familiarity with the range of regulatory requirements at all development stages
Technical writing
Papers or articles
●Determine/confirm suitability for journal and appropriate article type
●Drafting abstract, text, formatting references all in accordance with instructions for authors
●Electronic submissions and accompanying forms
●Revisions, corrections and resubmission
Development reports
●Manufacturing reports including: analytical, qualification, validation, stability, bridging, process development and investigation reports
●Biocompatibility and Biological Evaluation Reports (BER) & chemical evaluation report (CER)
●Nonclinical study reports (in vitro and in vivo) in accordance with regulatory expectations.
Medical reports
●Clinical study reports in accordance with ICH/GCP
●Data Safety Update Reports (DSUR)
●Clinical evaluation reports (CER)
●Post marketing surveillance reports (PMS)