Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers providing high quality data analysis & statistical report writing in accordance with regulatory standards
- High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution.
- Integrated study report writing in eCTD format with hyperlinking & bookmarking.
- Preparation of FDA Summary Tables for ANDA Submissions.
- Custom format reports.
- CD-ROM copy and hard copy of reports and associated study data.
- CS-BE preparation for TPD submissions.
- Preparation of abstracts, manuscripts, publications & poster presentations
- Experienced-based study protocol & ICF development.
Our standard reports are prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports". Past experience and regulatory expertise ensures that reports are written to minimize any possible delay in regulatory approvals.