Our medical writing services include clinical and regulatory writing, as well as scientific papers, education material and medical writing consultancy. Examples include:

Clinical and Regulatory Writing:

• ICH compliant clinical study reports (CSRs; Phase I to IV including pediatric)
• NI-PASS compliant CSRs
• Study protocols, amendments, and administrative changes
• Regulatory documents (e.g., briefing books, summaries, overviews)
• Investigator brochures
• Patient information/consent documents and narratives
• Standard operating procedures (SOPs)

Scientific and Educational writing:

• Manuscripts
• Conference abstracts (posters and slide sets)
• Medical marketing reviews and reports
• Promotional and educational material

Appraisals of 4Pharma Medical Writing team by our customers

“Since the early 2000s, we have been working with 4Pharma’s medical writing team while developing our proprietary products. We sought a team that would not only be experienced in our core therapeutic area, but would also have expertise in clinical studies, drug development, and regulatory strategy. We found all this, and more, in 4Pharma. The team has helped us design clinical protocols and evaluate our clinical results, written over two dozen ICH compliant CSRs for our various projects, and even joined with us at FDA and European regulatory meetings”

“The draft CSR was very well written, I believe the next version should be the penultimate version and we can move quickly to a final CSR”

“Without doubt this milestone could not have been achieved without the exceptional teamwork, as well as passion and dedication, shown by the team. Thank you for being an important part of this team”

“This exemplary effort not only achieved internal objectives but will allow this important and innovative product to become available to patients as soon as possible”