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Navigating the regulatory landscape

Organizations in the pharmaceutical and biologic industry must keep pace with rapidly changing regulatory requirements from around the globe. In addition to daily submission activities, regulatory operations groups must find a way to stay current and implement updates through the development and maintenance of processes, standards, training, and adoption.

Our subject matter expertise and deep experience across regulatory functions help you navigate this fluid environment and optimize your processes and implementations.

CGI’s regulatory optimization practice

CGI has expertise across product development and post marketing activities including regulatory, clinical, supply chain and manufacturing, labeling, and information management.

As a non-software client services organization, we operate with complete non-bias in process development, system implementations, and vendor selection processes.

During identification of medicinal products (IDMP) evaluations, we provide required services for our partner organizations.

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Regulatory operations optimization services

Process development

Identify gaps in processes, draft and edit policies, implement best practices, and train staff.

Template support

Develop and review templates and train users on best practices.

Systems support

Provide non-biased support for vendor tool selection process, software implementation, validation, and migration activities.

Regulatory intelligence

Interpret and implement guidance and provide training.

Electronic submission support

Provide electronic common technical document (eCTD) compliance assessments and global dossier planning.

Electronic submission preparation

Analyze, evaluate and implement requirements and provide training.

Regulatory operations harmonization

Process and standardize data across all electronic submission systems and tools.

Training

Develop and deliver training across all electronic submission systems and tools.

Electronic submission strategy

Develop a plan to expand electronic submissions into new markets.

System gap analysis

Evaluate and report opportunities for maximizing value of current systems and tools.