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PharmWrite

Efficient Regulatory Submissions Made Easy. Simplify regulatory obligations with PharmWrite. Our digital solution leverages machine learning, OCR, and analytics to ensure compliance.

HOW DOES IT WORK?

I WANT PHARMWRITE

Experience automated submissions with PharmWrite.

I WANT PHARMWRITE

PharmWrite is a digital solution that allows organizations and sponsor companies to manage their regulatory submission obligations in an automated, centralized way. The platform utilizes various technologies, including machine learning, natural language processing, advanced OCR, and analytics, to enable compliance with applicable laws and regulations. Data collected within the platform can be analyzed for insights that help the organization comply with changing legal requirements. Additionally, the platform can help an organization react quickly to regulations or market conditions changes, allowing them to remain competitive without sacrificing compliance or delay to approval.

PharmWrite offers automation, centralized management, insights, analytics, adaptability to regulatory changes, and specialization in FDA submissions and CMC aspects. Choosing PharmWrite can enhance an organization’s regulatory compliance, streamline processes, and facilitate successful approvals for regulated products.

Why choose PharmWrite

Automation and Centralized Management

PharmWrite offers a digital regulatory platform that automates and streamlines the management of regulatory submission obligations. By utilizing advanced technologies such as machine learning, natural language processing, and OCR, the platform enables organizations to handle their regulatory processes more efficiently. This automation reduces manual work, minimizes errors, and ensures compliance with applicable laws and regulations.

Insights and Analytics

PharmWrite’s platform collects and analyzes data, providing valuable insights that can help organizations comply with changing legal requirements. By leveraging analytics capabilities, organizations can gain a deeper understanding of their regulatory landscape, identify patterns, and make informed decisions. These insights enable proactive compliance measures and help companies stay ahead of regulatory changes, ultimately saving time and resources.

Quick Adaptation to Changes:

Regulatory environments are dynamic, with evolving laws and market conditions. PharmWrite equips organizations with the ability to react swiftly to these changes. By utilizing the platform’s functionalities, companies can stay competitive without sacrificing compliance or facing delays in approval processes. PharmWrite enables agile responses to regulatory updates, ensuring that organizations can navigate the shifting landscape effectively.

Focus on FDA Submissions and CMC

PharmWrite specializes in FDA submissions and CMC (Chemistry, Manufacturing, and Controls) aspects of regulated products. This specialization allows organizations to benefit from a platform tailored to the specific requirements and intricacies of FDA submissions. PharmWrite’s expertise in these areas ensures that organizations receive comprehensive support and guidance throughout the submission process, improving the chances of successful regulatory approval.

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Enhanced Submission Creation with Enkrisi: The First-Ever Hybrid Model Consultancy

For many biotechnology companies, maintaining a full complement of product development experts, from drug development technical experts to submission authors and regulatory professionals is impossible. However, lacking access to these experts hinders the progress of product development.

PharmWrite’s hybrid model consultancy distinguishes itself through the combination of automation and expertise, data-driven insights, agility in the regulatory landscape, and specialization in FDA submissions and CMC. By embracing this innovative approach, PharmWrite empowers organizations to achieve regulatory compliance efficiently, make informed decisions, adapt to changes seamlessly, and maximize their chances of successful approvals.

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Key aspects

Augmented Intelligence is a form of A.I. that works in tandem with humans to make decisions rather than replace human Intelligence. It uses machine learning and deep learning algorithms to provide actionable data to help humans make informed decisions. Machine learning allows A.I. systems to learn and improve from experience. Natural language processing lets computers understand our spoken language, while deep learning helps them “think” like the human brain and find patterns in large data sets. Augmented Intelligence starkly contrasts traditional artificial Intelligence, which seeks to replace human labor and decision-making altogether.

Automation and Centralization

PharmWrite works by leveraging automation and centralization to streamline regulatory compliance processes. Organizations can upload their regulatory submission materials to the platform, which utilizes advanced technologies like machine learning, natural language processing, advanced OCR, and analytics. These technologies automate manual tasks, extract relevant information from documents, and streamline data entry, reducing the risk of errors and saving time. The centralization aspect allows all stakeholders involved in the compliance process to access and collaborate on the platform, ensuring transparency, efficiency, and consistency in managing regulatory obligations.

Data Analysis and Insights

A key aspect of PharmWrite is its ability to collect and analyze data, providing valuable insights for regulatory compliance. The platform's analytics capabilities enable organizations to gain a deeper understanding of their regulatory landscape. By analyzing trends, patterns, and historical data, organizations can proactively identify potential compliance risks, make data-driven decisions, and optimize their compliance strategies. PharmWrite empowers organizations to extract actionable insights from vast amounts of regulatory data, facilitating more effective compliance management and reducing the chances of non-compliance.

Expert Guidance and Collaboration

PharmWrite offers expert guidance and collaboration throughout the regulatory compliance process. Organizations can access a team of regulatory professionals who specialize in FDA submissions and CMC aspects. These experts provide personalized guidance, ensuring that organizations understand and meet the regulatory requirements for their specific products. PharmWrite fosters collaboration between regulatory professionals, compliance teams, and other stakeholders by providing a centralized platform for communication and document sharing. This collaboration ensures that all parties are aligned, reducing miscommunication and streamlining the compliance process.

Adaptability and Scalability

PharmWrite is designed to adapt to the evolving regulatory landscape and accommodate the needs of organizations of all sizes. The platform enables organizations to quickly adapt to regulatory changes, whether they are updates to laws, regulations, or market conditions. With PharmWrite, organizations can easily modify their compliance strategies, update submission materials, and implement new processes to remain compliant. Additionally, PharmWrite offers scalability, allowing organizations to handle a growing volume of regulatory submissions efficiently. As organizations expand their product portfolios, PharmWrite can support the increased compliance workload, ensuring continued regulatory success.

How does it work?

PharmWrite simplifies regulatory compliance by automating submission management, offering centralized data storage and collaboration features, providing data analysis for proactive compliance, and offering customization and scalability options. By utilizing PharmWrite, organizations can streamline their regulatory processes, enhance efficiency, ensure transparency, and reduce compliance risks. PharmWrite empowers organizations to navigate the complex regulatory landscape with ease, ultimately achieving successful regulatory approvals.

We’re constantly striving for better solutions. Our business processes are efficient and transparent so you can see how we perform at every stage of your project.

01
Automated Regulatory Submission Management
PharmWrite works by providing organizations with a digital solution for managing their regulatory submission obligations. Through the platform, organizations can automate and streamline various tasks involved in the regulatory compliance process. The platform utilizes advanced technologies such as machine learning, natural language processing, advanced OCR, and analytics to automate data extraction, document management, and compliance tracking. By automating these tasks, PharmWrite minimizes manual work, reduces the risk of errors, and improves overall efficiency in managing regulatory submissions.
02
Centralized Data Storage and Collaboration
One of the key aspects of PharmWrite is its centralized data storage and collaboration capabilities. Organizations can upload their regulatory submission materials, including clinical data, manufacturing information, and labeling, to the platform. This centralized storage ensures easy accessibility and secure management of all relevant documents. Furthermore, PharmWrite facilitates collaboration among stakeholders involved in the compliance process. Regulatory professionals, compliance teams, and other authorized users can access and collaborate on the platform, enabling seamless communication, document sharing, and real-time updates. This centralization and collaboration enhance transparency, consistency, and accountability in regulatory compliance.
03
Data Analysis and Insights for Proactive Compliance
PharmWrite goes beyond automation and storage; it also provides data analysis and insights to support proactive compliance management. The platform leverages its analytics capabilities to process and analyze regulatory data. Through data-driven insights, organizations can gain a deeper understanding of their regulatory landscape, identify compliance risks, and make informed decisions. PharmWrite enables organizations to detect patterns, trends, and potential compliance issues, allowing them to take proactive measures to address them. By leveraging data analysis, organizations can optimize their compliance strategies, reduce non-compliance risks, and enhance overall regulatory success.
04
Customization and Scalability for Diverse Needs
PharmWrite is designed to accommodate the diverse needs of organizations in managing their regulatory compliance. The platform offers customization options to tailor the compliance process to each organization’s specific requirements. PharmWrite can adapt to various regulatory frameworks and product types, ensuring compatibility and compliance across different industries. Moreover, the platform provides scalability, allowing organizations to handle a growing volume of regulatory submissions as their business expands. PharmWrite’s scalability ensures that organizations can efficiently manage increased compliance workloads, supporting their regulatory success in the long term.

FAQs

What is PharmWrite?

PharmWrite is an augmented intelligence regulatory CMC authoring tool. It combines advanced technologies like machine learning, natural language processing, and analytics to provide a digital platform for efficiently managing regulatory submission obligations. PharmWrite’s focus on CMC aspects enables organizations to streamline the authoring process and ensure compliance with regulatory requirements.

How does PharmWrite ensure compliance with changing regulatory requirements?

PharmWrite, as an augmented intelligence regulatory CMC authoring tool, enables organizations to stay compliant with changing regulatory requirements. By leveraging its advanced technologies, PharmWrite assists in the authoring and management of CMC submissions. The platform automates repetitive tasks, provides insights through data analysis, and guides users in meeting evolving regulatory standards, thus ensuring timely and accurate compliance.

What sets PharmWrite apart from other regulatory tools?

PharmWrite distinguishes itself as an augmented intelligence regulatory CMC authoring tool, offering a unique approach to compliance management. With its advanced technologies, PharmWrite enhances efficiency in CMC authoring, streamlines processes, and reduces the risk of errors. The platform’s augmented intelligence capabilities empower users with insights and guidance throughout the regulatory journey, enabling organizations to navigate changing regulatory landscapes effectively. PharmWrite’s focus on CMC specifically caters to the needs of organizations seeking regulatory approval for drugs and biologics, making it a valuable tool in the pharmaceutical industry.

Who do we serve?

PharmWrite facilitates the writing of regulatory submissions by providing an intuitive platform that guides users through the process, ensuring comprehensive and compliant documentation. With its augmented intelligence capabilities, PharmWrite automates repetitive tasks, offers templates and guidance, and assists in data analysis, resulting in more efficient and accurate regulatory submissions.

Small Emerging Biotech

PharmWrite provides small emerging biotech companies with a user-friendly platform that simplifies the regulatory submission process, ensuring compliance and helping them navigate the complex regulatory landscape with confidence.

CMOs and Academia

PharmWrite assists Contract Manufacturing Organizations (CMOs) and academia by offering a streamlined regulatory submission platform that simplifies the authoring process, enhances compliance, and accelerates approval timelines, enabling efficient collaboration and success in the regulated environment.