SPL Conversions - Techsol Life Sciences

Regulatory Operations Updates

Structured Product Labeling (SPL) Conversions

Our services ensure your product’s labeling is structured, accurate, and fully compliant, whether you're launching a new product, making safety updates, or managing delisting.

Accurate and Timely SPL Conversions for Regulatory Compliance Across Global Markets

Structured Product Labeling (SPL) and other regulatory data conversions require precision and expertise to ensure compliance with regulatory standards. At Techsol Life Sciences, we specialize in providing precise SPL conversions that meet FDA, EMA, and other regional authority requirements.

We Support:

Our SPL Conversion Services

Techsol Life Sciences offers end-to-end SPL services to ensure your labeling is compliant with global regulatory standards throughout the product lifecycle—whether creating, updating, or delisting products.

SPL Creation & Validation

We ensure your SPL is compliant with FDA and HL7 standards, including accurate header data, labeling content, and error-free validation for eCTD submission.

SPL Updates

We update your SPL to reflect new safety information, clinical data, and regulatory changes, including revised warnings, contraindications, and dosage information.

SPL Delisting

We manage delisting by updating the product’s status in the FDA database and removing it from public sources like DailyMed.

Legacy Data Conversion

We convert older labeling formats to the current SPL format, ensuring compliance with FDA and HL7 standards for future regulatory processes.

Techsol’s SPL Management Approach

Techsol follows a structured process for SPL creation, updates, and delisting, ensuring full compliance and accuracy.

Regulatory Strategy: We align SPL submissions with FDA guidelines and PLR requirements.
Gap Analysis: Identify missing or incomplete data in headers, drug details, and labeling content.
Data Collection: Collaborate with clients to gather up-to-date labeling and safety information.
SPL Authoring & Conversion: We create and convert SPL into compliant XML format, including necessary sections like IFUs.
Validation & Error Resolution: Validate using FDA tools and resolve any errors to meet HL7 and ICH standards.
Final QC Review: Conduct a final review to ensure content accuracy and regulatory compliance.

Techsol's Advantage in SPL Conversion Services

Techsol Life Sciences offers a comprehensive and reliable approach to SPL conversion, providing high-quality, compliant, and accurate SPL submissions. We help ensure that your product labeling meets the regulatory requirements of FDA.

Key Benefits of Working with Techsol:

Regulatory Expertise: Our team is well-versed in FDA SPL guidelines, HL7 standards, and ICH compliance.
End-to-End SPL Lifecycle Management: We offer a full range of services from SPL creation and updates to delisting, ensuring your products stay compliant throughout their lifecycle.
Accuracy & Compliance: We ensure all SPL submissions are error-free and meet the highest standards of regulatory compliance.
Timely Submissions: We can handle urgent submissions, ensuring SPLs are delivered on time even under tight deadlines.

Contact Techsol Life Sciences for SPL Conversion Services

If you need expert help with SPL creation, updating, or delisting, Techsol Life Sciences is here to guide you through every step of the process. Our experienced team ensures that your SPLs are fully compliant with FDA, EMA, and other regulatory standards, helping you meet your regulatory goals.

Get in touch today to learn how our SPL Conversion Services can support your global regulatory strategy.

RLD Update Services

Our RLD update services are designed to meet the evolving needs of global pharmaceutical companies, ensuring that product labels are consistently updated in compliance with the FDA, and other regional authority requirements. Our comprehensive service includes:

Label Comparison with RLD

We provide a side-by-side comparison between your product’s label and the latest approved Reference Listed Drug (RLD) label. This ensures that every modification to the label aligns with current regulatory standards.

Redline and Clean Versions

Our team produces redline versions that highlight all the modifications (additions, deletions, or edits) made to the label, ensuring full transparency. Additionally, we deliver a clean version of the label, ready for submission or publication.

Annotated Patient Information Leaflet (PIL)

We annotate the Patient Information Leaflet (PIL), providing context for each label change, such as new safety information, updated dosage instructions, or revised regulatory details. This enhances the clarity and transparency of the updates for both regulatory reviewers and healthcare providers.

Compliance Documentation

For every update, we provide a detailed compliance report, documenting each change and ensuring it aligns with regulatory guidelines. This includes documenting justifications for any deviations from the RLD, where applicable.

Version Control and Audit Trail

We maintain a full audit trail of all label revisions, enabling full traceability of changes across multiple versions, ensuring compliance and regulatory clarity.

Techsol’s Expertise in RLD Updates

At Techsol Life Sciences, we understand the complexities involved in aligning product labeling with ever-changing RLD requirements. Our team of regulatory affairs experts, clinical writers, and compliance professionals brings a wealth of knowledge and experience in managing regulatory labeling requirements across global markets.

We specialize in the following areas:

Regulatory Strategy and Planning: We work with your team to develop a regulatory strategy that ensures compliance across multiple regions, whether the focus is on the FDA or other international authorities.
Standardized Labeling Process: We use a standardized checklist to ensure that all relevant label sections such as active ingredients, safety warnings, indications, and dosage instructions are reviewed and updated accurately.
Cross-Regional Expertise: We have a deep understanding of regulatory requirements in various regions, ensuring that your labeling is compliant with local and international standards.

Why Choose Techsol for RLD Updates?

Regulatory Compliance Expertise: With years of experience in global regulatory affairs, we ensure your labels meet the latest FDA and regional requirements for both initial product launches and ongoing updates.
Streamlined and Efficient Process: Our end-to-end process, from redline creation to final clean labels and side-by-side comparisons, is designed for speed and efficiency. We understand the importance of timely submissions and ensure all updates are processed promptly without compromising accuracy.
Custom Solutions for Complex Products: We handle both simple and complex products, whether you are working with generic drugs under ANDA or biologics requiring more intricate regulatory documentation.
Automated Workflows: We implement automated workflows for side-by-side comparisons, data validation, and document formatting, which reduces manual errors and streamlines the entire process.
Transparency and Traceability: Every label update is tracked and documented, providing full transparency and traceability. Our clients can be assured that all modifications are fully compliant and in line with regulatory expectations.

Techsol’s Approach to RLD Updates

Our approach to RLD updates ensures that all modifications are fully aligned with regulatory requirements and are processed in a way that reduces risk and ensures timely submissions. The steps include:

Redline Version: This version highlights all changes, providing a clear view of what has been modified, added, or removed from the previous label.
Clean Version: This is the final, updated version of the label, free from any mark-up, and ready for final submission.
Annotated PIL: We provide context for each change, ensuring that each modification is clear and justifiable.

Benefits of RLD Updates with Techsol

Partnering with Techsol Life Sciences for Reference Listed Drug (RLD) updates ensures sponsors achieve the highest levels of accuracy, efficiency, and regulatory confidence. Our expert team meticulously tracks and integrates changes to labeling, safety information, and product characteristics, ensuring that all updates are precise and fully aligned with current health authority expectations. By streamlining the RLD update process, we enhance operational efficiency, reduce the risk of noncompliance, and enable faster decision-making during regulatory submissions. With our global compliance expertise, sponsors can maintain harmonized labeling across regions, mitigate regulatory risks, and ensure seamless alignment with USFDA, EMA, MHRA, Health Canada, and other global authorities.

Ready to Update Your RLD Labels?

At Techsol Life Sciences, we make RLD updates seamless and compliant, ensuring that your product labels always meet regulatory standards. Whether you are working with ANDA, FDA regulations, we provide the expertise and tools you need for accurate, timely label revisions.

Contact us today to discuss how we can assist you with RLD updates and labeling compliance. Let’s ensure your product labeling is always up to date with the latest regulatory standards!!!!