Regulatory Staffing Services

Meet your regulatory staffing needs with X Pharma Plus.
Our experienced professionals manage submission activities, ensure compliance with global regulatory standards, and enable seamless regulatory operations.

Regulatory Staffing Services – Overview

To ensure the confidentiality of medicinal products and maintain complete visibility of daily regulatory activities, many manufacturers rely on external regulatory staffing support. However, finding qualified regulatory talent remains a significant industry challenge.

X Pharma Plus provides expert regulatory staffing solutions to bridge resource gaps efficiently and on time. With a proven track record of successful deployments, we help clients meet their organizational needs while ensuring compliance and smooth regulatory operations.

Services

“Regulatory Staffing Services provide on-demand access to skilled regulatory professionals, ensuring flexible, cost-effective support for submissions, compliance, and product lifecycle needs.”

A Regulatory CMC Strategist ensures that the chemistry, manufacturing, and controls (CMC) aspects of a drug are compliant, well-documented, and aligned with global regulatory requirements for faster approvals.

Provide regulatory consultation during product development and manufacturing, including selection of RLD/Reference Standard
Guide design of specifications, protocols/reports for development, process validation, exhibit batches, and stability studies
Confirm composition against reference drug and support stakeholder interactions on regulatory matters
Facilitate Health Authority interactions and manage submission strategies and roadmaps
Lead the regulatory team, coordinate with management, and handle Health Authority queries with strategic and scientific justification.

A Regulatory CMC Expert provides specialized guidance on drug development, manufacturing, and quality controls to ensure compliance with global regulatory standards.

Develop and execute regulatory submission strategies for initial and post-approval submissions
Conduct gap analysis and assess source data for regulatory adequacy
Review draft CTD sections for submissions, including INDs, IMPDs, NDAs, MAAs, BLAs, DMFs, and lifecycle management submissions
Guide stakeholders on regulatory requirements, manage submission timelines, and mentor the regulatory team
Prepare response strategies and review packages for Health Authority queries

A Regulatory CMC Associate supports the preparation, review, and submission of CMC documentation to ensure drug products meet global regulatory requirements.

Perform gap analysis of source documents and author CMC modules for initial and post-approval submissions
Support change control evaluation, lifecycle management, and tracking of submission timelines
Implement regulatory submission strategies, coordinate with stakeholders, and prepare responses to Health Authority queries
Conduct knowledge-sharing sessions to ensure team awareness of regulatory updates

Access to experienced regulatory contract staffing services for global clients
Tailored solutions to meet specific regulatory staffing requirements
Proven expertise in deploying qualified regulatory professionals to support submissions and compliance

Regulatory Staffing Services