Global Regulatory guidance and advice, leadership and informed insight to set and implement successful Regulatory strategies to all stages of product development, gap assessments of existing product development programs, Regulatory roadmaps, strategies for special designations and accelerated pathway approaches, coaching and preparation for communication and interactions with Health Authorities, and assistance with Regulatory submission planning and authoring.
Strategic development and execution of Global CMC content from preparation to review for submission to Health Authorities and the management of related responses.
Comprehensive support for implementation of the EU Clinical Trial Regulation 536/2014 from consultancy and training to uploading your Part 1 and Part 2 documents as an extension of your in-house team. From CTR compliance, implementation, and advisory services to operational support in CTIS, our team ensures that your EU clinical trial submissions are made in a timely and efficient manner through CTIS. Our services include redaction and deferral strategy & support, project management, compilation, validation, and substantial modification management, ensuring compliance & regulatory efficiency throughout the clinical trial.
Global experience with the review and approval of promotional materials (drugs, biologics, medical devices), launch planning, advisory comment and interactions with OPDP/APLB. Expert leadership in the development and/or review of procedures and workflows, as well as ongoing analysis of industry trends. Our experienced and collaborative ad promo consultants help clients meet their goals with a balanced approach to achieving business needs while maintaining compliance with industry standards and regulations.
We offer comprehensive support for eCTD submissions. Our approach is based on ongoing collaboration and knowledge transfer, ensuring that you and your team are fully prepared and compliant with the latest eCTD regulatory requirements. With 24x7 operations, our team ensures that submissions are made in a timely and efficient manner. We have well-defined processes in place to continually improve consistency, efficiency, quality control, and risk mitigation. Our services include eCTD submission strategy, project management, compilation, validations, submissions via gateway, and lifecycle submission management to ensure compliance throughout the product's lifecycle.
Expert guidance on the creation and implementation of global labeling strategies for the development and commercialization of pharmaceutical, biotech and medical device products. Focused leadership in the creation and/or review of labeling procedures and associated workflows, and in the management/support of label content with Health Authorities.
Our services for Word formatting and publishing documents ensure that your submission documents meet the eCTD PDF specification requirements and are prepared in a way that makes them easy to navigate and review. We take care of the technical details so that you can focus on the content of your document. The CTD Word template suite is designed to simplify the process of creating compliant submission documents, allowing clients to focus on the content rather than formatting. With a common structure and an easy-to-use toolbar, the templates enable users to quickly apply commonly used styles. By implementing the template suite, authors can streamline the process, ensure consistent formatting, and save time and effort.