Regulatory business automation
Life Sciences companies are seeking transformative ways to put the patient at the center of their innovations. The answer lies in digital strategies that truly make the patient the center of innovation and reduce the time to market.
Our software suite gives life sciences companies the tools they need to accelerate innovation and reduce time-to-market for new therapies, devices, and medicines. Prana’s proven expertise helps customers improve business agility and operational efficiency.
Prana4Life Regulatory Information Management (RIM) Platform
Securely integrate and connect compliance components to easily manage all regulatory affairs content, data and workflows on one holistic, unified platform.
Prana4Life Regulatory Solution Suite
Simultaneously publish and submit new drug applications in multiple markets and in compliance with a variety of regulatory formats. Built with a single user interface, this suite includes Consulting, Veeva Suite, Medidata, Salesforce, CRM, Migration, Publisher, Viewer, GXP validation and administration modules.
Prana4Life Commercial Solution Suite
Consulting, Veeva Suite, Medidata, Salesforce, CRM, Migration With a unified data model and advanced capabilities only available on the Vault Platform, Vault CRM Suite delivers greater agility and insights to customer-facing teams.
Managed Services
- Prana4Life Pharmacovigilance
- Prana4Life MigrationPro
- Implementation Services
- High Value Consulting
- Training Services
- Supply Chain Management (link to the new page)
- Analytics and Data Lake Services
Audits and compliance
We provide audit support for FDA and various third-party audits, in addition to being compliant with 21 CFR part 11 and EU Annex 11. Our auditors provide on-site audits, IT audits, and periodic reviews for internal and external organizations. We perform assessments and generate Risk and Assessment documents in addition to offering management and support for Deviations and CAPAs.
We adhere to industry compliance regulations and standards for Life Science companies:
- Pharmaceutical
- FDA 21 CFR Part 11
- EU GMP Annex 11
- ISO 9001
- 21 CFR Parts 210 & 211
- Medical Devices:
- ISO 13485
- FDA 21 CFR Part 820
- ISO 14971
CSV
We perform retrospective validation for the systems that have an impact on regulatory compliance during inspections and audits. We also define and implement change management processes alongside data security procedures in accordance with ALCOA principles.
Veeva Vault Implementation
We provide a host of Veeva vault services for a variety of solutions. In addition to the setup, configuration, migration, and product release to Vault services, we also offer integration from CTMS to EDC systems. We also provide end-to-end solutions for Veeva Regulatory Information Management (RIM) systems, operations support, release management, configuration management, and Veeva GxP validation.
eTMF & CTMS
In addition to our clinical trial validation services, we offer implementation, support, validation, and integration services for eTMF and CTMS.
Data migration/integration
We offer customized solutions based on migration requirements. In addition, we also offer a mature delivery model for the migration of legacy applications containing large data sets, complex relationships, audit trails, and digital signatures. Our Veeva Vault certified team’s expertise with data migration tools and platforms presents a solidified approach to ownership of validation and tool qualification.
