Designing your research study is just part of planning your regulatory strategy. From our long experience of interacting with the Food and Drug Administration (FDA) and other regulatory agencies, on behalf of Sponsors, we have accrued an impressive library of documents and best practices in many therapeutic areas that can help you avoid delays and pitfalls.
 

Our experience streamlines regulatory interaction and includes:
 

Drug products: IND, NDA, ANDA, 505(b)(2)
 

Botanicals: NDI, IND, NDA
 

Biologics: IND, BLA
 

Medical devices: IDE, PMA, 510(k) Clintract can provide a regulatory team with the expertise you need to plan and develop complete dossiers and submissions for every stage of the investigational new drug (IND) or investigational device (ID) process. Our services address all 5 eCTD modules.
 

Clintract staff keeps current with the evolving standards for electronic common technical document (eCTD) submissions and other regulatory guidances. Our electronic submissions use Clintract’s gateway (ESG) to FDA.
 

Regulatory Services
Clintract offers a comprehensive range of regulatory services for Sponsors of all sizes. The following highlights these services.
 

Strategic Planning

• Regulatory position and market analysis
• General investigational plan
• Study design and protocol development
• Study methodological development
• Enhanced access to specialists
• Deficiency responses

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Regulatory Interactions

• Act as U.S. regulatory agent

• Provide regulatory project management
• Coordinate and manage correspondence
• Plan, prepare for and facilitate meetings
• Coordinate and manage information requests

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Document Preparation
• IRB Submission Management
• Compile & submit regulatory documentation
• Prepare and integrate summary data
• Perform compliance reviews and assessments
• Implement literature searches
• Develop investigator brochures

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Electronic Submissions
• eCTD with XML metadata (backbone)
• Bookmarking and hyperlinking according to FDA standards
• IND life cycle management to enable faster NDA submissions
• Structured product labeling (SPL) and electronic drug and registration listings
• Electronic publishing
 

Before you start your next clinical trial, talk to Clintract about regulatory strategies that can inform your protocol design. Clintract regulatory services and expertise can help save time and avoid frustrating obstacles. Call to discuss your situation and upcoming needs.