Our Services

· Global and Local Regulatory Strategy

· Drugs, Biologics and Devices

· Orphan Drug Designation

· Health Authority Meetings

· Advisory Committee Meetings

· REMS, TPP, and Labeling (SPL/PLR)

· Expanded Access Programs

· Marketing and Launch Materials

· Inspection Readiness

· Regulatory SOP Development and

  Optimization 

 · Global Health Authority submissions

   (INDs, NDAs, IDEs, 510ks, PMAs,

    BLAs, MAAs, BIMO, DMFs and more)

· ICH-Compliant Electronic Submissions

· Submission Project Management

· Remote/Onsite Publishing

· Process Development

· SPL and PLR Labeling

· Electronic Datasets

· Study Design and Implementation

· Study Management and Monitoring

· Medical Writing

· Clinical SOP Development and

  Optimization

CrO's Regulatory Operations Center of Excellence (CROCE) provides you with a personalized, professional, turnkey regulatory operations department that serves as an extension of our clients Regulatory Affairs department. 

Our goal is to provide your organization with our regulatory experts, processes, publishing system, and archive to support the end-to-end submissions’ activities, as well as deliver published documents and/or submissions that are produced to the highest quality standards and in compliance with all applicable guidelines for submissions.

Vision, Strategy and Roadmap service includes taking a look at your organization's current state regardless of where you are in your journey, to determine a forward-thinking approach that aligns to your product development lifecycle. We offer unique methodologies that are up to date with current regulations, guidance's and the latest industry trends keeping us ahead of the curve every time. Focusing on people, processes and technology leaving our clients with a comprehension plan for success.   

R&D Systems Exchange services is designed to help you to align your technical and business needs across your entire platform by providing skilled resources well versed in industry best practices that have dealt with and overcome many of the same challenges you may be facing. Our services include project strategy, management, and governance to minimize risks and ensure critical milestones and deliverables are successfully managed and met. 

R&D Systems Exchange Service addresses the 4 Key Pillars required for success: 

   - Change Management
   - Data Excellence
   - Process Optimization
   - System Operability   

Strategic Vault Platform Planning service is designed to assist our clients with developing a strategic plan to implement the entire Vault Platform, implementing what you need, when you need it.   

R&D/Organizational Governance service focuses on overseeing the people, processes and systems to strategically plan for and ensure oversight and control early on as part of your road map and strategy. Including governance during your implementation, configuration, integrations, creation of procedures and throughout the lifecycle of your product development.   

Data Excellence service includes a deep look at your organization's data to ensure quality, cleansing, metadata optimization, constructive reuse of information across platforms, consistent migration of data, proper dispositioning, and compliance.   

Business and Systems Support service is designed to quickly address process and technical issues for business users, on behalf of our clients. Our team of experts is dedicated to analyzing the support statistics to determine where additional training is needed to ensure successful user adoption.    

The Premier GCP Inspection Readiness Initial Audit is the complete solution to review all trial-related activities to assess the current state of the study. 

This service allows our team to establish a baseline of how the client is currently managing inspection readiness activities as well as prepare for future mock inspections. 

The audit will review:

- systems: focusing on the functionality of complete systems (e.g., pharmacovigilance, data management)

- processes: focusing on the performance of specific processes within systems

- vendors: assessment of external service providers

- trial-specific: audits of all activities across a single trial

- investigator sites: assessment of trial activities in the clinical setting

- documentation: review of trial-specific or system documentation (e.g., computer system validation packages, etc.)