Risk Evaluation and Mitigation Strategies (REMS) Plan

Regulatory Operations

Our regulatory experts provide end-to-end REMS planning, submission, and maintenance services across the product lifecycle.

At Techsol Life Sciences, we support pharmaceutical and biotech companies in developing and implementing FDA-compliant Risk Evaluation and Mitigation Strategies (REMS) to ensure the safe use of drugs with known or potential serious risks. Our regulatory experts provide end-to-end REMS planning, submission, and maintenance services across the product lifecycle.

Risk Evaluation and Mitigation Strategy (REMS) is a regulatory program required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns to help ensure that the benefits of the drug outweigh its risks. REMS programs are designed to manage specific risks by reinforcing safe use conditions through communication, training, and monitoring.

Initial drug approval
Post-market safety evaluation
New information on known risks

Techsol’s REMS Support Capabilities

Techsol has a full range of capabilities and extensive experience supporting REMS programs for clients, including:

REMS Needs Assessment

Analyze drug safety profile and therapeutic indication
Evaluate whether REMS is required per FDA guidance
Conduct comparative risk analysis based on similar marketed products

REMS Document Preparation

Author REMS documents, including goals, elements to assure safe use (ETASU), communication plans, implementation systems, and assessment metrics
Prepare REMS Supporting Documents (RSD) for FDA submission

Submission & FDA Interaction

Compile REMS content in applicable modules of eCTD
Submit REMS documents with NDA/BLA or post-marketing supplements
Support responses to FDA REMS comments and negotiate final REMS structure

REMS Assessment & Modifications

Assist sponsors in preparing REMS Assessment Reports
Develop REMS modifications or revisions in line with safety updates
Monitor and maintain compliance with REMS implementation timelines

REMS Integration with Commercial and Safety Operations

Coordinate REMS implementation with pharmacovigilance and medical affairs teams
Ensure alignment with risk management systems globally (e.g., RMP in EU)
Support training of healthcare providers, distributors, and pharmacies as per REMS requirements.

Why REMS and ETASU (Elements to Assure Safe Use) Matter

These tools allow the FDA and drug manufacturers to protect patient safety while ensuring that necessary medications remain accessible. ETASU can enable the continued marketing of drugs that would otherwise be withdrawn due to risk concerns, by mitigating those risks effectively.

Techsol’s Expertise in REMS and ETASU Support

At Techsol Life Sciences, we support sponsors in developing and managing REMS programs, including:

REMS strategy development and FDA interaction
Design and documentation of ETASU components
REMS submission in eCTD format
Ongoing assessment and reporting support

Key Challenges in REMS

How Techsol Helps Overcome REMS Challenges

At Techsol Life Sciences, we:

Techsol Expertise

Regulatory Expertise: Deep knowledge of REMS regulatory framework and safety labeling requirements
ETASU Implementation Guidance: For products requiring Elements to Assure Safe Use (ETASU), we help sponsors develop structured and enforceable ETASU elements, including stakeholder certification processes, restricted distribution programs, and patient monitoring plans.
Techsol helps to ensure that your REMS program is FDA-compliant, operationally efficient, and aligned with public health goals.