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Core Services

We deliver specialized support in copyright permissions, licensing workflows, TMF management, and regulatory documentation for pharmaceutical and life-sciences teams. We streamline processes, reduce compliance risk, and ensure audit-ready accuracy across medical writing, submissions, and clinical operations.

1 

Permissions & Licensing Workflows

We partner directly with clinical, regulatory, and medical writing teams to ensure compliant use of third-party materials across all literature-driven functions.

 

Our support includes:

 

  • Managing end-to-end permissions workflows for literature references, images, tables, presentations, datasets, and other third-party content

  • Centralizing clearance requests, tracking approvals, and maintaining documentation for audit and submission readiness

  • Working closely with business lines to fulfill medical writing and literature requests accurately and efficiently

  • Implementing standardized processes that minimize delays and reduce risk of copyright misuse

2

Publisher & CCC Licensing Support

We serve as your dedicated rights & licensing partner—reducing legal exposure, preventing cost overruns, and strengthening strategic publishing relationships.

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Services include:

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  • Negotiating, securing, and maintaining license agreements with major publishers and clearing houses (e.g., CCC)

  • Managing renewals, usage rights coverage, and cost optimization opportunities

  • Deploying automated content review technologies to identify potential copyright risk prior to dissemination

  • Integrating copyright screening tools into existing systems for proactive, real-time monitoring

3

Data Acquisition & System Setup

We ensure your copyright, TMF, and submission records move seamlessly during organizational changes, system upgrades, or transfers.

 

Capabilities include:

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  • Migrating copyright licensing agreements between teams, vendors, or organizations

  • Supporting buyer/seller transitions by transferring TMF and submission-ready content across platforms

  • Reviewing and securing literature materials for future reuse

  • Building and maintaining literature databases and uploading articles, manuscripts, and reference content

4

Compliance Monitoring & Reporting

We provide rigorous oversight to strengthen your copyright controls and ensure continuous compliance.

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Our services include:

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  • Conducting regular audits and gap assessments of current copyright practices

  • Monitoring news, industry updates, and public discourse for emerging risks

  • Performing post-marketing commercial literature searches to support submissions and compliance documentation

5

Trial Master File (TMF) Operations

We offer comprehensive TMF setup, management, and oversight to support inspection readiness and lifecycle documentation.

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Support includes:

 

  • TMF database setup, configured by zone and priority

  • Investigator onboarding and essential document tracking

  • Ongoing TMF monitoring to ensure completeness, accuracy, and compliance

  • Full lifecycle TMF support: study closeout, archiving, audits, and submissions

6

Regulatory Submissions & Clinical Project Support

We provide cross-functional project management and documentation support from Phase 1 through Phase 3, helping teams meet global regulatory expectations.

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Capabilities include:

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  • Managing compilation and delivery of IND, NDA, Annual Reports, DSUR, and MAA submissions

  • Providing labeling and SPL support

  • Developing and maintaining eCTD timelines while holding business units accountable to deliverables

  • Supporting Medical Writers in compiling CSRs, tables, appendices, and reference requests

  • Ensuring all documentation is audit-ready for FDA inspections and other regulatory authority reviews

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