Accurate FDA Consultants provides expert clinical affairs solutions to both medical device and pharmaceutical firms looking to navigate the complex regulatory landscape and bring their critical product to market.
Our Services ensure your clinical trials meet FDA and international regulatory standards:
Pre-Clinical & Strategy
- FDA and international regulatory authority consultations
- Pre-submission, IDE, and IND meeting management
- Clinical strategy development and risk assessment
Clinical Trial Management
- Protocol design and optimization
- IRB/Ethics Committee submissions
- Data management and monitoring
- Clinical report writing and review
- Site selection and patient recruitment
Usability & Human Factors
- Human Factors Engineering (HFE) protocol design
- Informed consent optimization
- Usability testing for medical devices and digital health solutions
Regulatory Compliance & Post-Market
- FDA and international submission preparation
- Quality management system (QMS) implementation
- Post-market surveillance and real-world evidence collection
Training & Education
- Customized GCP and regulatory requirement programs
- Regulatory Affairs professional development
Why Choose Us?
- Seasoned experts in clinical affairs and regulatory compliance
- Tailored strategies for your product and regulatory pathway
- Efficient processes to optimize development timelines
- Comprehensive support throughout your product’s lifecycle
Contact us today for a complimentary consultation. Let’s discuss how we can advance your clinical affairs projects efficiently and effectively.
