KNOWLEDGE, SKILLS AND RESOURCES TO MANAGE YOUR LABELING NEEDS – FROM START-TO-FINISH
Optimus 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.
Optimus 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.
Optimus 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 barcoding practices.
Optimus also provides XML Structured Product Labeling for the Pharmaceutical Industry. Structured Product Labeling (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 labeling
- 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 labeling documents including Core Data Sheets (CCDS)
- Supporting regulatory/labeling, pharmacovigilance, medical, clinical, marketing and legal departments.
- Labeling decision making structure for development products and postmarketing labeling changes
- Structure and features of Core Data Sheets, guidance/manual for populating implementable Core Data Sheets
- Labeling project management systems (management of requests, documentation of decisions, implementation tracking, integration in product knowledge bases)
- Labeling databases and document management systems (tracking and auditing systems)