Email Us

Streamline Your Regulatory Pathway with Expert Regulatory Operation Services

Navigating the complexities of Regulatory Operation can be challenging, but you don't have to do it alone. At Willingjet, we specialize in providing comprehensive Regulatory Operation services to ensure all your submissions are efficient, compliant, and successful. Our tailored solutions cater to pharmaceutical, biologic, and medical device applications across global markets.
CONTACT US NOW

Comprehensive Regulatory Operation Services

Submission Compilation and Publishing
Submission Compilation and Publishing

Successfully navigate the complexities of drug, biologic, and medical device submissions with our expert submission compilation and publishing services. We ensure that all your submission dossiers are accurately formatted and compliant with regional regulatory requirements. Our team manages everything from submission planning to submission delivery to health authorities.

Product lifecycle Management
Product lifecycle Management

Maintain the integrity and compliance of your product across their entire lifecycle. We provide meticulous updates, amendments, and renewals to keep your dossier current and compliant. With our proactive approach, you can anticipate and address regulatory changes efficiently.

Regulatory Strategy and Consulting
Regulatory Strategy and Consulting

Leverage our deep industry knowledge and regulatory expertise to develop robust strategies for your applications. We offer customized consulting to help you understand regulatory pathways, identify potential hurdles, and optimize your approach for faster approval.

Global Submission Capabilities
Global Submission Capabilities

Expand your reach with our global submission capabilities. We have extensive experience in preparing and managing all submissions formats including eCTD and other format across multiple regions, e.g., U.S. (FDA), E.U. (EMA), Japan (PMDA), China (NMPA). Our team support all your global regulatory activities.

Compliance and Quality Assurance
Compliance and Quality Assurance

Rely on our stringent quality control processes to ensure your submissions are error-free and meet all regulatory guidelines. Our comprehensive quality control process to ensure the compliance for all dossiers with current regulations, thus minimizing the risk of rejection due to non-compliance.

Regulatory Process Optimization and enhancement
Regulatory Process Optimization and enhancement

We could help client to optimize their dossier execution process, complete eCTD transition via process and system for emerging market and establish data visualization solution in regulatory operation management.

Service Process

The typical process of our Regulatory Operation service is illustrated in the image below. We offer flexibility in working with either the client's system or our own. Let's take eCTD submission as an example.

Service Process

Case Study: Accelerating Regulatory Approval with Streamlined Regulatory Operation Services

  • Background

A leading pharmaceutical company specializing in the development of innovative oncology therapies sought assistance in preparing and submitting their New Drug Application (NDA) for a groundbreaking cancer treatment. With a revolutionary therapy on the brink of approval, the client recognized the critical importance of flawless Regulatory Operation submissions to expedite the regulatory process.


  • Challenge

The client faced the challenge of compiling and formatting a vast array of complex clinical and nonclinical data into a coherent Regulatory Operation submission package. Additionally, they needed to ensure compliance with stringent regulatory requirements across multiple regions, including the FDA (U.S.) and EMA (Europe).


  • Solution

Partnering with Willingjet, the client accessed a comprehensive suite of Regulatory Operation services tailored to their specific needs. Our team of regulatory experts collaborated closely with the client to develop a strategic submission plan, leveraging our extensive experience in oncology and regulatory affairs.


  • Key Steps Taken

1. Comprehensive Document Management: Our team meticulously organized and compiled all necessary documentation, including clinical trial data, nonclinical studies, and CMC information, into a structured Regulatory Operation format.

2. Regulatory Strategy Development: We worked closely with the client to develop a robust regulatory strategy, identifying potential challenges and optimizing the submission timeline for maximum efficiency.

3. Global Submission Management: Leveraging our expertise in global submissions, we prepared and managed Regulatory Operation submissions for regulatory bodies worldwide, including the FDA and EMA, ensuring compliance with regional requirements.

4. Quality Assurance and Error Correction: Rigorous quality checks were conducted at every stage of the submission process to identify and address any errors or inconsistencies promptly. We provided full support for managing questions from regulatory agencies and implementing necessary revisions to ensure a successful approval process.


  • Results

  • Accelerated Approval Timeline: Through our streamlined Regulatory Operation services, the client successfully navigated the regulatory pathway, accelerating the approval timeline for their groundbreaking cancer therapy.

  • Compliance Assurance: Our comprehensive approach to regulatory compliance ensured that the submission met all regulatory standards and requirements, minimizing the risk of rejection or delays.

  • Strategic Partnership: The client benefited from a strategic partnership with Willingjet, gaining access to expert guidance, personalized support, and a proven track record of regulatory success.


  • Conclusion

By partnering with Willingjet for their Regulatory Operation needs, the pharmaceutical company achieved expedited regulatory approval for their innovative oncology therapy. Our tailored services and strategic expertise played a pivotal role in streamlining the submission process, ensuring compliance, and ultimately bringing life-saving treatments to patients in need.


Frequently Asked Questions About Our Regulatory Operation Services

What is Regulatory Operation? What is Regulatory Operation?

The essential responsibility of regulatory operations is to submit regulatory dossiers to health agencies in a compliant format including eCTD, NeES, electronic and paper. Regulatory operation is responsible to work with the colleagues in all departments to ensure dossiers format requirements.

What is eCTD? What is eCTD?

The Electronic Common Technical Document (eCTD) is the standard format for submitting health regulatory applications digitally. It is used globally by pharmaceutical, biotechnology, and medical device industries to submit documents to regulatory authorities in a structured and efficient manner.

Why is eCTD submission required? Why is eCTD submission required?

eCTD submission is required because it ensures a consistent, organized, and efficient review process for regulatory approvals. Many regulatory agencies, including the FDA, EMA, and PMDA, mandate submissions in this format to streamline their workflows and facilitate quicker decision-making.

What is the status for eCTD implementation? What is the status for eCTD implementation?

eCTD is mandated and required for most established markets, including the United States, the European Union, the United Kingdom, Australia, Canada, and voluntary for more markets, including GCC, Switzerland, South Africa, Japan, China, Thailand, etc.

How does your service ensure my submission is compliant with regulatory standards? How does your service ensure my submission is compliant with regulatory standards?

Our service ensures compliance by staying updated with the latest regulatory guidelines and requirements. We utilize comprehensive checklists and quality assurance processes to review every element of your submission, ensuring that all documents meet the necessary standards and formats required by regulatory agencies.

How can you help us with our global submission strategy? How can you help us with our global submission strategy?

We can assist you in setting up a global submission strategy. We are familiar with regulatory operations in all regions and can support you in establishing a wave of global submissions. Additionally, we are experts in managing multiple submissions to ensure all timelines are met.

What happens if there are errors in the submission? What happens if there are errors in the submission?

If any errors are identified either by our team during the quality checks or by the validation after submission to regulatory authority. We will promptly address and correct these errors. We provide full support for managing questions from agencies and implementing necessary revisions to ensure a successful approval process.

How do you handle updates or amendments to existing eCTD submissions? How do you handle updates or amendments to existing eCTD submissions?

We manage all aspects of lifecycle management for your eCTD submissions, including updates, amendments, and renewals. Our services ensure that your dossier is always current and compliant with the latest regulatory requirements.

What makes your eCTD services different from others? What makes your eCTD services different from others?

Our eCTD services stand out due to our expertise, precision, and commitment to client success. We offer personalized attention, tailored strategies, and extensive regulatory knowledge, ensuring not just compliance but a strategic advantage in your regulatory submissions.

Key Components of an eCTD Submission? Key Components of an eCTD Submission?

Here are key components:

  • Administrative and Prescribing Information: Covers all the essential details about the submission, including application forms and the comprehensive table of contents.

  • Module 1: Specific to each region and includes regional administrative information.

  • Module 2: Summaries of the quality, clinical, and nonclinical data.

  • Module 3: Quality (pharmaceutical documentation and chemistry, manufacturing, and control information).

  • Module 4: Nonclinical Study Reports.

  • Module 5: Clinical Study Reports.


Why Choose Our RO Services

01
Streamlined Submission Process

Our RO services streamline the entire submission process, reducing complexity and eliminating the stress of managing technical requirements. By optimizing document management and submission timelines, we help you focus more on innovation and less on administrative burdens.

02
Enhanced Regulatory Compliance

Stay ahead of regulatory changes with our expert guidance. We ensure that your submissions are always compliant with the latest regulations and guidelines. This proactive approach minimizes the risk of submission rejections and accelerates the approval process.

03
Global Market Access

Expand your product’s reach with our expertise in global regulatory submissions. From North America to Europe to Asia, we navigate the specific requirements of each region to facilitate smoother entries into diverse markets, helping you achieve a truly global footprint.

04
Faster Time to Market

Speed up your product’s time to market with our streamlined RO services. Our efficient document preparation and submission strategies significantly cut down approval times, helping you bring your products to market quicker than ever.

05
Dedicated Expert Support

Gain peace of mind with dedicated support from our team of regulatory affairs experts. We offer personalized assistance throughout the submission process, ensuring you have expert guidance every step of the way.

06
Data Security and Integrity

Trust in our commitment to maintaining the highest standards of data security and integrity. We use advanced security protocols to protect your sensitive information throughout the submission process, ensuring that your data remains confidential and secure.

ISO 9001
ISO 9001
ISO 17100
ISO 17100
ISO 13485
ISO 13485
ISO 27001
ISO 27001
ISO 14001
ISO 14001
ISO 28000
ISO 28000
Get in Touch
Ready to learn more about our Regulatory Operation services? Contact us today!
CONTACT US
Featured Services
Medical Translation
Your trusted partner in medical document translation for the past 20+ years.
Medical Writing
Crafting clear, compliant, and compelling medical documents to accelerate your clinical and regulatory success.
IP Services
Protecting your ideas, securing your future globally.
Interpretation
Contact us to get a quote in 48 hours with equipment solutions and talent options that best meet your need.
Related Posts
Navigating the Changing Landscape: Translator Growth in the Era of Artificial Intelligence
Navigating the Changing Landscape: Translator Growth in the Era of Artificial Intelligence
In the dynamic realm of translation, the advent of artificial intelligence has not only revolutionized the tools and techniques at translators' disposal but has also transformed the very nature of...
Navigating the Changing Landscape: Translator Growth in the Era of Artificial Intelligence 12 07 2024
The Impact of AI Technology on Translation Costs
The Impact of AI Technology on Translation Costs
In the rapidly evolving landscape of translation technologies, Artificial Intelligence (AI) has introduced significant shifts in how translation services are rendered and priced. As AI continues to ad...
The Impact of AI Technology on Translation Costs 12 07 2024
Unlocking Efficiency in Life Sciences Translation Management with TMS
Unlocking Efficiency in Life Sciences Translation Management with TMS
Translation Management System (TMS) plays a pivotal role in streamlining and optimizing translation processes, and its significance in the field of life sciences cannot be overstated. In this article,...
Unlocking Efficiency in Life Sciences Translation Management with TMS 11 07 2024
Enhancing Medical Translation Efficiency with Translation Memory
Enhancing Medical Translation Efficiency with Translation Memory
IntroductionIn the dynamic field of medical translation, the role of Translation Memory (TM) has become increasingly pivotal, revolutionizing the way pharmaceutical content is translated. Understandin...
Enhancing Medical Translation Efficiency with Translation Memory 10 07 2024