As a leading Contract Research Organization at DivergentCRO, we offer a comprehensive suite of eRegulatory services designed to streamline and optimize regulatory processes for pharmaceutical, biotechnology, and medical device companies. Our services focus on reducing operational burdens, ensuring compliance, accelerating time to market, and cutting costs. Through innovative technology, expert-driven strategies, and efficient processes, we ensure a seamless regulatory journey from drug development to commercialization.

 

 

A secure, cloud-based platform for managing all regulatory documents. This ensures real-time access, version control, and audit trails for internal teams and external stakeholders.

 

Electronic Common Technical Document (eCTD) Submissions: 

We specialize in preparing and submitting regulatory applications using eCTD formats to the FDA, EMA, MHRA, and other global regulatory bodies.

 

Non-eCTD Electronic Submissions (NeeS): For countries or regions still requiring non-eCTD submissions, we provide expert guidance and support to ensure compliance with local formats.

 

Automated Submission Workflows: Our technology-driven workflows ensure that documents are correctly compiled, reviewed, and submitted, reducing errors and ensuring faster approval timelines.

 

With our constantly updated regulatory database, we provide clients with the latest regulatory requirements, guidelines, and trends for over 150 countries, allowing for informed strategic decisions.

 

 

Pre-Submission Regulatory Strategy: 

We assist clients in developing robust regulatory strategies, ensuring that they meet global and local requirements while maximizing approval potential. This includes gap analyses, pre-IND/IMPD meetings, and regulatory pathway assessments.

 

Regulatory Risk Assessments: 

Proactive identification of potential regulatory challenges, enabling companies to mitigate risks early in the development process, saving time and reducing costs.

 

Digital Application Management: 

End-to-end management of regulatory applications, including Investigational New Drug (IND), New Drug Application (NDA), Marketing Authorization Application (MAA), and Biologics License Application (BLA) submissions.

 

 

Automated Publishing Tools: 

We use cutting-edge technology to automate the publishing of regulatory submissions, minimizing human error and ensuring compliance with submission standards.

 

Integrated Collaboration: 

Our platform allows real-time collaboration between sponsors, CROs, and regulatory bodies, ensuring seamless communication and faster resolution of queries.

 

4. Electronic Trial Master File (eTMF) Solutions eTMF Setup and Maintenance: We provide a cloud-based eTMF platform for clinical trials, ensuring that all essential documents are securely stored, indexed, and available for regulatory inspections.

  

 Real-Time Audit Readiness: Our eTMF solution allows for continuous monitoring of document compliance, ensuring that your files are always ready for inspection by regulatory authorities.

 

Automated Document Tracking and Archiving: 

 

Keep track of document completion, signatures, and archiving through automated workflows and customizable dashboards.

 

We perform in-depth reviews of all documents before submission to regulatory agencies to ensure compliance with global standards, reducing the chances of rejection or delays.

 

 Vendor Qualification Audits: Comprehensive audits of third-party vendors to ensure that all aspects of the regulatory submission process adhere to compliance standards, ensuring a seamless workflow.

 

Mock Regulatory Inspections: 

We simulate real regulatory inspections, preparing your teams for the questions and processes they will encounter during regulatory reviews, ensuring successful outcomes.

 

 Annual Reports and Safety Updates: Preparation and submission of regulatory-required reports such as IND Annual Reports, Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).

 

Regulatory Change Management: Continuous monitoring and submission of regulatory variations, including amendments to INDs, NDAs, and MAAs, to ensure compliance throughout the product lifecycle.

 

Labeling Submissions:

 Expert guidance on developing and submitting labeling requirements, including medication guides, package inserts, and summary of product characteristics (SmPC).

 

Post-Marketing Surveillance and Reporting: Comprehensive management of post-marketing requirements, including adverse event reporting, pharmacovigilance activities, and regulatory maintenance of approved products.

 

 Regulatory Filing for Line Extensions: Support for post-approval regulatory submissions, including line extensions, new formulations, or additional indications for approved products.

 

Lifecycle Management: 

Continuous oversight of your product’s regulatory status, ensuring compliance with evolving regulatory requirements and maintaining approvals across different regions.

 

 

Our dedicated regulatory project managers oversee the entire submission process, from planning and document preparation to submission and approval. We ensure timely submissions and regulatory compliance.

 

Tailored Consulting Services: 

Our regulatory experts offer bespoke consulting services for unique challenges such as accelerated approval pathways, orphan drug designation, pediatric plans, and fast track submissions.

 

 Global Expertise, Local Knowledge: 

While we provide global regulatory expertise, we also have an in-depth understanding of regional regulatory requirements, ensuring that submissions are tailored to meet specific local standards.

 

 

Our systems ensure full compliance with data integrity standards such as FDA’s 21 CFR Part 11, GDPR, and ISO 27001.

 

We employ advanced cybersecurity measures to protect sensitive regulatory documents from breaches and unauthorized access, ensuring that your data is safe at all times.

 

Blockchain for Regulatory Compliance: Our innovative use of blockchain technology provides an immutable audit trail for regulatory submissions, enhancing data security and integrity.

 

Our services are tailored to fit your project’s size and scope, ensuring that you only pay for the services you need.

 

Cloud-Based Solutions: Leveraging cloud technology minimizes infrastructure costs while maximizing accessibility, efficiency, and security.

 

By automating various aspects of the regulatory submission process, we reduce labor costs and improve turnaround times without compromising quality.

 

Why Choose Our eRegulatory Services?

Our innovative eRegulatory services offer pharmaceutical and biotechnology companies the opportunity to streamline their regulatory workflows, ensuring faster submissions, better compliance, and significant cost savings. With our experienced team of regulatory professionals and cutting-edge technology, we deliver flexible, scalable, and compliant solutions that adapt to the evolving needs of the industry.