Regulatory Affairs

ClinChoice’s publishing teams support regulatory submission processes globally throughout the entire product lifecycle. We strategize on regulatory publishing and submission for regulatory documentation worldwide, ensuring compliance with regional and national regulations. ClinChoice has expertise in technical standards and gateway submission management to health authorities like FDA, TGA, EMA, and others, covering initial pre-market applications, clinical reports, document-level, and submission-level publishing—encompassing conversion, optimization, OCR, bookmarking, hyperlinking, document properties, quality review, and validation.

Our in-house services include end-to-end artwork development, including regulatory intelligence applications , content creation, graphic design, proofreading, updates to existing artwork, and review of new and existing artwork.

• Preparation and finalization of labeling content for global submission requirements, including but not limited to USFDA, EMA, Japan, Canada, and the rest of the world countries
• Global regulatory expertise in medical device and diagnostic labeling requirements
• Instructions for use authoring, review, and maintenance
• Global and local label creation and maintenance
• Label review for compliance
• Roadmap development for content reuse
• Standard operating procedure (SOP) development
• Reviewing labels with respect to symbols applicable to a device and Unique Device Identification (UDI) requirement
• Lifecycle management per EU MDR regulations, which includes creating, revising, and evaluating contraindications, warnings, precautions, Instructions for Use (IFU)
• Creating, reviewing, and routing design changes
• Documentation and maintenance of labeling procedures

With our skilled regulatory professionals and experienced quality control and assurance team, we help you ensure regulatory compliant labeling thereby reducing legal cost, minimizing product recalls, and improving patient outcomes.

ClinChoice’s experienced teams develop and manage complex dossiers and technical files using the latest regulatory intelligence and industry-leading best practices.

• Data collation for technical documentation, GSPR, and clinical evaluation (CER)
• Technical documentation and GSPR authoring
• Development and management of performance evaluation documents for IVDs
• Toxicologist support for biocompatibility risk assessments
• Human-factor engineering support for usability studies
• Dossier structure review for global regulations
• Gap analysis to identify documentation deficiencies
• Pre- and post-market data review for clinical and performance evaluation reports
• Risk file and product specification development

ClinChoice excels in providing robust product registration support through regulatory strategists and in-country affiliates. We prepare documentation and submissions in country-specific formats, facilitating submissions via health authority portals. Our team assesses design history files (DHF), Technical Documentation and medical device files (MDF) to ensure alignment and compliance with the latest regulatory requirements. Beyond regulatory submissions, ClinChoice offers comprehensive Quality Management System (QMS) ISO 13485 certification support.

ClinChoice supports change management processes and requirements for medical device design, development, and manufacturing, including quality management system documents. We author justifications for change in compliance with regulatory requirements, prepare change packets for submission to health authorities or notified bodies, and handle query responses.