Services

We want our clients to feel our work before signing in. We can mutually agree for a small task or section designed to consume max.16 hours for free of cost. This way we want our clients to gain confidence and trust in us which is the basis of any relationship.We strive to write documents and present data in a clear and well-structured manner. We believe in being proactive and take ownership of client’s requirements from beginning to end of the process.Our medical and related services are grouped into 2 domains. An overview of the most common services within each domain is provided below. We can offer more services and solutions besides those listed below. Contact us to learn more about our services and how we can meet the specific requirements and needs of your company.

Regulatory documents (Clinical/Safety)

  • Clinical Evaluation Reports (CERs)
  • Post market documentations (PMCF, surveillance documents such as PSUR, PBRER and so on)
  • Audit reports
  • Risk management documents and related activities
  • Safety Narratives
  • Clinical protocols
  • study reports (CSR) and summary documents (both clinical and non clinical)
  • DSUR

Regulatory documents (Clinical/Safety)

  • Clinical Evaluation Reports (CERs)
  • PSUR/PBRERs
  • User manuals
  • DSURs
  • Safety Narratives
  • Risk management document and etc.,

Technical Documents

  • Product requirements
  • Procedures
  • Validation documents
  • Service manuals
  • Installation Procedures and etc.

GET IN TOUCH

We offer professional clinical/regulatory/technical writing solutions to medical device, IVD, pharma and biotech companies.

FOR GENERAL ENQUIRY