Compliant, well-written and accurate documents as per standard formats for regulatory approvals
With an increased regulatory rigor on transparency in sharing clinical data and pharmacovigilance strategies during clinical development, the demand for writing services is surging rapidly. Wipro provides medical writing services to our Pharmaceutical, Biotechnology and Medical Devices clients supporting the entire drug development lifecycle – preclinical to post marketing stages covering activities such as planning, authoring and reviewing of documents, publishing and submission. Our team of medical writers and SMEs (subject matter experts) are highly skilled professionals and possess thorough understanding of the drug development process, ICH-GCP regulatory guidelines and rules across different geographies, thus providing clear and concise scientific documents. We provide end-to-end services across product lifecycle with flexible resourcing model to provide significant cost benefits to our clients.
Our services include:
- Clinical Trial documents: protocol, informed consent, clinical study reports, patient narratives
- Labeling documents: patient information leaflets, CCDS, package inserts, labelling updates etc.
- Publications: manuscripts, abstracts, conference posters and handouts, review articles
- Disclosure documents: plain language summaries, protocol registration, results disclosure
- Standalone support services: copyediting, copywriting, proof reading, standalone QC