Regulatory Affairs

We collate and analyze the latest regulatory changes and their impact on clinical development and product registrations . Our global and local teams leverage regulatory information and updates gathered from in-country affiliates and health authorities to formulate successful regulatory strategies. We curate and tag intelligence from various sources with annotations and summaries, then generate global and country-specific summary reports on trends, regulatory updates, and insights.

• Device compliance
• Regulatory operations
• Regulatory data management
• Regulatory submissions
• Other business impacts

ClinChoice utilizes in-house regulatory intelligence to develop processes and checks, ensuring compliance with both mature and emerging market regulations. It involves managing various aspects, including the clinical investigation and evaluation process and regulatory documentation in alignment with global regulations based on device risk class.

• Regulatory gap analysis
• Pre-market regulatory submissions and product registrations
• Quality management system (QMS)
• Vigilance and risk management systems
• Labeling and unique device identification (UDI)
• EUDAMED submissions
• Economic Operator (EO) assessment
• Importer, distributor compliance
• Technical Documentation/GSPR/Design history file assessment

ClinChoice helps device innovators enter new markets and maintain registration statuses in existing markets with a deep understanding of complex regulations, knowledge of product-specific nuances, and engagement with health authorities.

• Strategy setup from the start of product development
• Market selection for launch based on regulatory complexity
• Level of evidence needed based on the device risk and target market
• Competitive landscape and target market assessments
• Gap identification and regulatory pathways
• Documentation reviews for new and existing products
• File, dossier, evidence, and QMS evaluations
• Support for FDA Q-subs and EU conformity assessment routes

ClinChoice leverages a team of regulatory strategists and in-country affiliates for first-time-right product registration and submissions to health authorities. From preparation to submission of documentation and applications through health authority portals, we offer an array of registration support services.

• Clinical, safety and performance, and risk document review
• Technical documentation and GSPR authoring
• Development and submission support for IDE, 510(k), Dual Submissions, PMA, DeNovo, EUA and more
• Registration of local and foreign establishments
• Comprehensive support for ISO 13485 certification
• Authoring of standard operating procedures and detailed work instructions
• Organization of required documents for product registration and continued market access
• Support with legal documents for import and export
• Preparation of new or updates to clinical and performance evaluations and technical documents
• Support for major FDA submissions – IDE, 510(k), PMA

ClinChoice’s experienced teams lead complex dossiers and technical file development using the latest regulatory intelligence and industry-leading best practices.

• Data collation and authoring of technical docs, GSPR, and clinical evaluation
• Toxicologist support for biocompatibility risk assessments
• Human-factor engineer support for usability studies
• Dossier structure review for global regulations
• Gap analysis to identify documentation deficiencies
• Clinical data review for CER compilation
• Risk file and product specification development
• Medical device manufacturing documentation
• Support for review, development, and management of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER) for Analytical Performance, Clinical Performance, and Scientific Validity to demonstrate the safety and performance of diagnostics

ClinChoice provides high-quality artwork and labeling services with hybrid delivery models to manage global and local labeling requirements that meet regulatory standards and enhance patient safety.

• Instruction authoring, review, updates, and maintenance
• Global and local label creation and maintenance
• Label review for compliance
• Roadmap development for content reuse
• Standard operating procedure (SOP) development
• Unique Device Identification (UDI) services

ClinChoice provides specialized regulatory copy review services through a team of skilled reviewers who collaborate with local compliance affiliates to review graphics, websites, social media, and promotional materials for completeness and accuracy. We thoroughly examine regulatory compliance and claims substantiation. ClinChoice’s services also encompass the finalization of regulatory information and approval of ongoing updates to product artwork on websites, social platforms, and promotional content.

ClinChoice’s publishing teams support medical device and IVD submission processes globally, managing entire product lifecycles. We strategize on regulatory publishing and submission for regulatory documentation worldwide, ensuring compliance with regional and national regulations. ClinChoice excels in gateway submission management to health authorities like FDA, TGA, EMA, and others, covering clinical reports, document-level, and submission-level publishing—encompassing conversion, optimization, OCR, bookmarking, hyperlinking, document properties, quality review, and validation.

ClinChoice employs in-house regulatory strategists and local affiliates to facilitate the preparation, registration, and maintenance of regulatory data in the European Database for Medical Devices (EUDAMED). We assess the supply chain and regulatory activities for data submission, create an inventory of devices subject to EUDAMED requirements, and submit data for EO registration to obtain Actor ID/SRNs. ClinChoice identifies and supports process improvements for efficient data submission, assessing the organization’s overall readiness for EU regulatory reporting requirements.