Knowledge, Skills and Resources to manage your Labeling needs – From Start-to-Finish
Vyomus Consulting offers a full range of professional services to centrally manage the entire label life cycle – from initial design & review to obsolescence for regulated manufacturers in the Life Sciences (i.e. pharmaceutical, medical device and biotech) industry.
Vyomus Consulting also offers complete protocol breakdown, regulatory review, and consultation for clinical studies. We have also partnered with a globally recognized translation company to provide translation services in this space. These services coupled with our industry leading labeling methodology can reduce clinical label cycle times from months to just a few weeks.
Vyomus Consulting is highly experienced in developing and reviewing all labelling documentation for India, US and EU markets, in full accordance with existing legislation. This includes core data sheets, Summary of Product Characteristics, Patient Information Leaflets, inner and outer package labels and bar coding practices.
Vyomus Consulting also provides XML Structured Product Labelling for the Pharmaceutical Industry. Structured Product Labelling (SPL) is an XML standard used by the United States Food and Drug Administration (FDA) to facilitate the communication of drug labeling data reliably among various groups such as hospitals, doctors, pharmacies, and the general public. SPL is both an HL7- and ANSI-approved standard.
Our services in this area include :
- Development of Investigational Brochure (core safety information) and development of Target Product Profiles and target Labelling
- Authoring and designing effective and defensible labelling content and format implementation before filing
- Assistance in case of regulatory requests to correct non-compliant proposed labeling content
- Authoring or updating Labelling documents including Core Data Sheets (CCDS)
- Supporting regulatory/Labelling, pharmacovigilance, medical, clinical, marketing and legal departments.
- Labelling decision making structure for development products and post marketing Labelling changes
- Structure and features of Core Data Sheets, guidance/manual for populating implementable Core Data Sheets
- Labelling project management systems (management of requests, documentation of decisions, implementation tracking, integration in product knowledge bases)
- Labelling databases and document management systems (tracking and auditing systems)
Discuss Your Needs
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