Pharmaceutical Technical Writing Services
Pharmaceutical technical writing services include a range of specialised writing tasks tailored to the needs of the pharmaceutical industry.
Services We Offer
Clinical Trial Protocols (CTPs)
Clinical Study Reports (CSRs)
Clinical Study Report Verification
Regulatory Submission Document
Medical Research Report
Standard Operating Procedures (SOPs)
Drug Safety and Pharmacovigilance Writing
Drug Development Documents
What are the reasons for errors in regulatory documents?
- Non-compliance with regulatory guidelines
- Poor scientific language
- Incomplete or inconsistent information
- Inattention to Detail
- Limited Understanding of Regulations
- Limited Data Management Tools
How can you structure effective documents for regulatory & scientific impact?
We write your reports to:
Format and submit your data according to the latest CDSCO data standards. We can also comply with international standards like FDA, EMA, etc.
Conduct a thorough examination of the impact of atypical data patterns on the overall robustness of submission efficacy and safety conclusions.
Detect unusual data patterns within or across studies, serving as an alert for potential issues. This step is critical for providing transparency to the reviewers.
Process for creating well-written Pharmaceutical documents
Step 1
Develop a content strategy
Step 2
Draft with scientific rigor
Step 3
Review and editing
Step 4
Quality assurance
Step 5
Approval and submission
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