REGULATORY AFFAIRS

Regulatory Support Across Clinical

Development and Product Lifecycle

CEBIS supports pharmaceutical development programs with regulatory planning, clinical trial application support, ethics activities, submission documentation and post-authorization regulatory services.

Regulatory activities can be coordinated with clinical operations, medical writing, data and safety teams throughout development.

REGULATORY PLANNING

A Regulatory Path Built

Around the Product

CEBIS provides regulatory consulting to help sponsors plan development and product-lifecycle activities around key regulatory milestones.

Regulatory Planning

Identify key regulatory activities based on the product and development stage.

Development Milestones

Align regulatory work with clinical and product-development activities.

Regulatory Coordination

Maintain communication and follow-up around required regulatory activities.

Lifecycle Support

Support regulatory needs that continue after initial product development or authorization.

STUDY START-UP

Regulatory Support

for Clinical Trial Authorization

Clinical Trial Application (CTA) support can include initial applications, substantial amendments, non-substantial modifications and additional member-state applications.

Application Preparation

Coordinate required clinical trial application documentation.

Submission Support

Support the required regulatory submission process for the study.

Amendments & Modifications

Manage applicable regulatory changes during study conduct.

Regulatory Follow-Up

Support responses and ongoing regulatory activities after submission.

ETHICS APPROVALS

Regulatory and Ethics Activities Working Together

Study start-up can require both regulatory and ethics-review activities. CEBIS supports regulatory and EC/IRB submissions, amendments and ongoing reporting activities as required by the study.

Support can include:

Ethics / EC / IRB submission coordination
Required study documentation
Submission follow-up
Study amendments
Ongoing documentation requirements
Coordination with study start-up teams

REGULATORY DOCUMENTATION

Organizing Product Information for Regulatory Review

The Common Technical Document (CTD) provides a structured format for regulatory product information.

Regulatory documentation support can include:

CTD-related document coordination
Product and clinical documentation
Study-supporting regulatory materials
Review of required submission components
Coordination with medical writing and other contributors

EU REGULATORY SUPPORT

Support for European

Regulatory Pathways

European registration routes can include:

LIFECYCLE MANAGEMENT

Regulatory Support Beyond

Initial Authorization

Post-authorization regulatory support can include product launch activities, line extensions, variations and maintenance of regulatory status through the product lifecycle.
Support can include:

Post-Authorization Activities

Coordinate regulatory requirements following authorization.

Variations

Support regulatory changes affecting the approved product information or lifecycle.

Line Extensions

Support relevant regulatory activities for product extensions.

Lifecycle Maintenance

Coordinate ongoing regulatory requirements over time.

INTEGRATED DOCUMENTATION

Regulatory Strategy Supported by Clear Study Documents

Regulatory activities often depend on documents produced across clinical development. CEBIS can coordinate regulatory support with medical writing for protocols, Investigator Brochures, CRFs and informed-consent forms.

CEBIS can coordinate regulatory work with:

Protocol development
Investigator Brochures
Informed Consent Forms
Clinical study documentation
Study reports
Other regulatory-support documents

CROSS-FUNCTIONAL SUPPORT

Regulatory Activities Connected to Clinical Delivery

Regulatory work affects multiple parts of the development program.

CEBIS can connect Regulatory Affairs with:

Need Regulatory Support for Your Development Program?

Tell us about the product, development stage, target markets, planned studies and regulatory activities you require. A member of the CEBIS team can discuss the appropriate support.