Grant and Technical Writing

Grant and technical writing requires a close partnership with the client to gain a deep understanding of the product/process. Moreover, in addition to high level writing skills, GSAP’s familiarity with regulatory compliant development plans for drugs, biologicals, advanced therapy medicines, as well as medical devices is a huge asset. Gsap has highly trained, native English speakers with experience in submitting papers and obtaining national, international, public and privately funded grants. In addition, Gsap has seasoned professionals with extensive technical writing competence covering all documentary requirements, including: protocols, study reports, technical evaluations and business plans. For a winning paper or grant, it’s crucial to grasp all the elements required for telling a compelling story, that addresses an unmet need. Gsap will ensure that the quality of the paper/application reflects a high quality product.

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)

●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)