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Regulatory Affairs
We provide comprehensive support for Regulatory Affairs including mapping out Regulatory pathways in different geographies and hands-on support for Regulatory Submissions and follow-ups till the final outcome of Applications
Health Authority Consultations
We have established strong relationships with health authorities, particularly in India, and through our partners in other geographies. Our expertise allows us to facilitate early health authority consultations for complex products, such as cell devices, gene therapy products, or fixed-dose combinations, new chemical entities, which may be challenging to translate into clinical settings.
For these consultations, we arrange meetings for our clients with the health authorities to discuss and gain insights into the perspectives of the regulators on such products. This enables our clients to make informed decisions and navigate the regulatory landscape more effectively.
Regulatory Advice and Operations
Our regulatory experts at Nextvel provide bespoke advice to clients seeking guidance in specific areas of regulatory affairs. Whether it is obtaining licenses for manufacturing for test analysis and clinical trials, clinical trial approvals and manufacturing for sales and distribution or navigating the complexities of a particular regulatory pathway, we draw upon our extensive knowledge and network of specialists to deliver tailored solutions.
In addition to advisory assistance , we offer operational support to clients who require assistance in executing regulatory strategies. Our team can act as an extension of your organization, leveraging our connections and expertise to help you navigate the regulatory landscape efficiently and effectively. With our support, you can focus on your core business while we handle the regulatory heavy lifting.
Making Regulatory Submissions to Indian Authorities, USFDA, EMA
Nextvel offers comprehensive support for regulatory submissions to major global health authorities, besides the Indian regulatory bodies. We have collaborators and partners in the US to coordinate the US Food and Drug Administration (USFDA), and the European Medicines Agency (EMA) Submissions. Our experienced team assists clients in preparing and submitting high-quality dossiers that meet the specific requirements of each regulatory authority.
For submissions to Indian authorities, we provide direct support and guidance, ensuring compliance with local regulations and streamlining the submission process. For US and European submissions, we collaborate with our trusted partners who have deep expertise in these regions, ensuring that your dossiers are prepared to the highest quality standards and submitted efficiently.
Dossier Preparations
Our dossier preparation services cover a wide range of geographies and regulatory requirements. We have a proven track record of preparing successful dossiers for various regulatory agencies, such as the US FDA (e.g., Investigational New Drug and New Drug Application) and the Australian Therapeutic Goods Administration (e.g., specific modules) and Health Canada.
Our team of medical writers, regulatory affairs specialists, and subject matter experts work collaboratively to develop comprehensive and scientifically robust dossiers that present your product aligned with your expectations and in the best possible light. We ensure that all the necessary data, information, and analyses are included, and that the dossiers are formatted and structured according to the relevant guidelines and standards.
Online / Physical Submissions
We understand that different regulatory authorities and product types may require different submission modes. We have the capability and experience to support both online and physical submissions, with a particular focus on submissions to Indian authorities.
Our team stays up to date with the latest submission requirements and platforms, ensuring that your dossiers are submitted accurately and efficiently. Whether it’s navigating online portals or preparing hard copies for physical submission, we handle the logistics and ensure that your submissions are delivered in a timely and compliant manner.
Support in Preparation of Presentations to Subject Expert Committee (Indian Regulatory Requirement)
Presenting to Subject Expert Committee (SEC) is a critical step in the regulatory approval process in India. At Nextvel, we provide comprehensive support in preparing compelling and scientifically rigorous presentations that effectively communicate the value and safety of your product when presented to these committee of experts for various therapeutics areas.
Our team of experienced medical writers and regulatory affairs professionals work closely with you to develop presentations that are tailored to the specific requirements of the expert committee. We ensure that the content is clear, concise, and persuasive, highlighting the key data and arguments that support your product approvals.
Support Sites with Ethics Committee Submissions
Navigating the Ethics Committee submission process can be challenging, particularly for sites that may not have extensive experience in this area. Our team provides hands-on support to sites, helping them prepare and submit Ethics Committee dossiers that meet the necessary regulatory and ethical standards.
We work collaboratively with sites to gather the required information, ensure that the dossiers are complete and compliant, and provide guidance throughout the submission process. Our goal is to streamline the Ethics Committee review process and help sites obtain timely approvals to initiate their clinical studies.
Support in drafting responses to queries raised by Ethics Committees and Regulatory Authorities
During the regulatory review process, it’s common for regulatory authorities or Ethics Committees to raise queries or request additional information. At Nextvel, we provide expert support in drafting accurate and comprehensive responses to these queries.
We understand the importance of timely query resolution in maintaining the momentum of the review process. Our team is committed to providing prompt and thorough responses, adhering to the deadlines set by the regulatory authorities or Ethics Committees.
Our query resolution support services include:
- Analysing queries and identifying the key issues to be addressed
- Gathering and reviewing relevant data and information to support the responses
- Drafting clear, concise, and scientifically robust responses
- Ensuring that responses are following the relevant regulatory guidelines and requirements
- Submitting the responses in a timely manner.
- Communicating with the regulatory authorities or Ethics Committees to provide any additional clarifications or information as needed
You can have confidence that your regulatory submissions will stay on track and that any concerns raised by the authorities will be addressed promptly and effectively.
Support in Regulatory Writing-Common Technical Document Modules
Our regulatory writing team has extensive experience in preparing all modules of the Common Technical Document (CTD), the standard format for regulatory submissions in many countries. We support clients throughout the drug development lifecycle, from the early stages of Investigational New Drug (IND) applications to the final stages of New Drug Application (NDA) submissions and until discontinuation of the product from the market.
We work closely with our clients to gather the necessary data and information, and we ensure that the final documents meet the specific requirements of the target regulatory authority.
For IND submissions, we often work with clients from the ground up, taking raw data and information from various sources and transforming it into well-structured and compliant CTD modules.
Marketing Authorizations and Product Registrations: India /US/EU
Nextvel has a proven track record of supporting clients in obtaining marketing authorizations and product registrations in key global markets, including India, the United States, and the European Union. Our team of regulatory affairs experts provide end-to-end support, from the initial filing strategy to the final approval.
Product registration is a critical step in bringing a new product to market, and it requires careful planning and execution to ensure compliance with the relevant regulatory requirements. We offer comprehensive product registration services to help clients navigate this complex process and obtain the necessary approvals.