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Denovo Biolabs provides dedicated Pharmacovigilance solutions during all phases of clinical development and post-marketing to Pharmaceutical, Biotechnology and Medical Device companies across globe. Our Pharmacovigilance team comprises of members who have years of Pharmacovigilance and safety management experience and Clinical Pharmacologists who have in-depth knowledge in diverse therapeutic areas.

Our dedicated Pharmacovigilance center offers high-quality services which include:


    • Global safety database set up and its maintenance.
    • Patient safety report collection from different sources including spontaneous, clinical trial and Literature reports.
    • Searching of Literature articles, review and selection of reports for potential adverse event/ reaction in compliance with regulatory requirements.
    • Selection and Analysis of adverse events/ reaction with respect to individual case safety reports.
    • Performing Medical review of case reports.
    • Online coding of drug and adverse event/ reaction (MedDRA; WHO Drug dictionary (WHO-DRL)).
    • Writing Case safety narratives.
    • Periodic Safety Update Reports (PSURs) preparation and submission to regulatory authorities.
    • Expedited reports preparation and submission to regulatory authorities.
    • Reconciliation of serious adverse events (SAE's) and safety database with CRFs.

    Highly dedicated team of medical writers, experienced in working on various regulatory documents across all phases of clinical development of drugs and all therapeutic areas including oncology, diabetes, women's health, cardiovascular. The medical writers have rich experience working in the industry with most of top Indian as well as international pharma companies. By education the writers are medically qualified, graduates and post-graduates (MBBS, BAMS, BHMS, M-Pharma) with good knowledge in clinical research, good clinical practices, and other regulatory guidelines.

    Regulatory documents:

    In Denovo, regulatory writing projects as such as clinical study reports/clinical trial reports, regulatory patient narratives, clinical trial registry documents and other safety and efficacy documents are undertaken. These documents written are as per ICH guidelines, sponsor templates & style guide, and FDA or other regulatory requirements.


    Writing high quality documents is of paramount importance. All the documents are internally checked and quality controlled. Medical reviews for patient narratives are performed internally.


    We have established regulatory document writing team. The talent pool at DeNovo is experienced in writing publication documents such as manuscripts, abstracts, posters and oral presentations. We are keen to expand our business area into Scientific Publication Writing.


We at Denovo Biolabs believe in delivering best quality work with best compliance and efficiency at all level at significantly low cost. We have intensive management plans to ensure that each and every SAE report that goes to reporting is best in quality and with 100% compliance and in accordance with regulatory guidelines. Denovo Biolabs provides "end-to-end' safety case processing by highly efficient safety experts. Denovo Biolabs believes in Patient safety as motto of their work and follow correct way to monitor drug safety trends while accumulating data, identify potential safety risks and take appropriate corrective and preventative action while the study is on-going.

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