Regulatory Data & Information Management Services

 

Life sciences companies need to constantly leverage on growing volumes of data and content while managing a host of formats for effective information management. Lumina Datamatics helps life sciences organizations to structure the unstructured elements of data and content while transforming ideas into reality with a host of customized information management services.

Regulatory Data Conversion

“Submission publishing” is a complex process in the ever-evolving regulatory environment. With new directives and guidelines, pharmaceuticals, bio-tech and medical device companies are facing real-time challenges to effectively handle the submission process across FDA, EMA, PMDA, and other health authorities.

Shorter timelines for meeting regulatory approvals while managing end-to-end submission life cycle from multiple formats to dossier preparation are also burdening the companies’ resources, budgets, and the entire submission process.

Lumina Datamatics provides .XML conversion services for the approval of drugs, biologics, and medical devices (NDA, ANDA, SPL, and MAA) that enable life sciences companies to efficiently and effectively meet their end-to-end submission requirements.

Document Management Services

Regulated industries like life sciences need to ensure compliance as a pivotal part of their document management for risk reduction and for gaining a competitive edge. Lumina Datamatics’ dedicated teams provide cost-effective document management services to manage and control regulated documents by providing a convenient and controlled access.

Lumina Datamatics helps in:

End-to-end document lifecycle management, with well-defined SOPs and audit trial
Building software-based integration kits between various departments, enabling systems to interact with each other and handle dataflows between systems
Creating control on electronic documents from being published, updated, approved or archived according to regulations.

Data Capture and Cleansing Services

Lumina Datamatics’ experienced team of data professionals understand that life sciences landscape is drastically changing due to persistent needs of effective data management.
Re-generation of legacy data into digitized and referenced form requires a structured approach for attaining optimal results in the process of data capture, data cleansing and archival.

Lumina Datamatics specializes in:

  • Text extraction from paper or scanned reports
  • Curation and quality-assured conversion
  • Mapping and conversion to desired extensions
  • Unit harmonization
  • Interpreting summary and tabulating source data

Artwork and Creative Services

Artwork management is one of the key functions that need to be effectively managed by pharma, biotech and medical devices companies. As a part of regulatory services, Lumina Datamatics offers robust solutions covering creative graphic design and artwork services for life sciences companies.

Our areas of expertise in artwork and creative services are:

Artwork Services

  • Artwork creation
  • Proofreading—technical check, text, and formatting
  • New product launch and branding
  • Product rebranding
  • Primary and secondary artworks
  • Patient information leaflets’ design

Creative Services

  • Design and layout services
  • Prepress services
  • Image retouching
  • Illustration
  • Logo creation
  • Branding and formatting
  • Cover page design
  • Newsletter creation
  • Scientific and medical books’ typesetting

Life Sciences Translation Services

Life sciences companies need effective translation services to help them with the Product Marketing Life Cycle of Discovery/Launch—Market across the globe. Lumina Datamatics helps pharma, biotech, medical devices, and clinical research organizations with the following translation services:

  • Multilingual regulatory compliance services
  • Clinical trial translation services
  • E-learning translation

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