RegWeb Consulting Services

RegWeb Consulting Services specializes in accelerating the registration process for therapeutics, enhancing patient access. Our team has extensive expertise in regulatory requirements across the US, EU, Canada, and Australia, and a proven track record of effective interactions with regulatory authorities. By leveraging our collective experience, we provide agile and high-quality solutions to complex regulatory challenges. Our unique approach integrates seamlessly with clients' in-house capabilities, ensuring efficient and compliant product development, registration, and commercialization.

Services include: 

• QMS implementation
• Internal audits
• Validation processes
• Continuous improvements
• CAPA process
• eQMS implementation migration and validation
• IND/CTA strategy and authoring
• NDA/NDS/ANDS/ANDA/MAA CMC strategy and authoring
• Publishing
• Regulatory Intelligence
• Regulatory submissions