Alta Stomatology is dedicated to advancing the field of oral disease drug research and development. With a commitment to innovation and excellence, our mission is to bring effective and safe treatments to market, improving the quality of life for those suffering from oral diseases. The journey from initial discovery to market introduction of a new drug is complex, involving rigorous regulatory processes to ensure safety, efficacy, and quality. At Alta Stomatology, we understand multiple countries' regulatory requirements and can provide comprehensive global regulatory support to guide you through every step of the drug development and approval process. If you have any needs, please feel free to contact us.
Our Services
Navigating the regulatory landscape is crucial for the successful development and commercialization of new drugs. Regulatory authorities such as the FDA (Food and Drug Administration) in the United States, EMA (European Medicines Agency) in Europe, and other global regulatory bodies set stringent guidelines to ensure that new drugs are safe and effective for public use. Compliance with these regulations requires meticulous planning, thorough documentation, and strategic communication with regulatory agencies.
At Alta Stomatology, our regulatory support services are designed to streamline this process, reducing the time and cost associated with bringing new oral disease treatments to market. We leverage our extensive industry knowledge and expertise to help you meet all regulatory requirements, from preclinical studies to post-market surveillance. Our goal is to ensure that your drug development program is compliant with all applicable regulations, thereby minimizing risks and maximizing the potential for approval.
Preclinical Support
The preclinical stage is critical for establishing the safety and efficacy profile of a new drug candidate before it enters human trials. Our team at Alta Stomatology provides comprehensive support for all aspects of preclinical research, including:
Regulatory Pathway Assessment
We help you identify the most appropriate regulatory pathway for your drug candidate, including options for accelerated approval or special designations that may expedite development.
Pre-IND Consultation
We assist in preparing for and conducting pre-IND (Investigational New Drug) meetings with regulatory authorities to ensure a clear understanding of the requirements for your IND submission.
Study Design and Protocol Development
Our experts collaborate with you to design robust preclinical studies that meet regulatory standards, including toxicology, pharmacokinetics, and pharmacodynamics studies.
IND Submission Preparation
From compiling the necessary data to writing and reviewing the IND application, we provide end-to-end support to ensure a complete and compliant submission.
Clinical Trial Support
Clinical trials are essential for demonstrating the safety and efficacy of new drugs in humans. Alta Stomatology offers a full range of services to support the successful execution of clinical trials:
Clinical Trial Design and Protocol Development
We work with you to develop scientifically sound and regulatory-compliant clinical trial protocols.
Regulatory Submissions and Approvals
Our team prepares and submits all necessary documents to regulatory authorities, including clinical trial applications (CTAs) and amendments.
Site Selection and Management
We assist in selecting appropriate clinical trial sites and provide ongoing support for site management and monitoring.
Data Management and Statistical Analysis
Our services include data collection, management, and statistical analysis to ensure accurate and reliable results.
Safety Monitoring and Reporting
We establish comprehensive safety monitoring plans and ensure timely reporting of adverse events to regulatory authorities.
New Drug Application (NDA) Support
The NDA submission is a critical milestone in the drug development process. Alta Stomatology provides expert guidance and support to ensure a successful NDA submission:
NDA Preparation and Compilation
We assist in preparing and compiling all necessary components of the NDA, including clinical and nonclinical data, manufacturing information, and labeling.
Regulatory Strategy and Communication
Our team develops a strategic regulatory plan and facilitates communication with regulatory authorities throughout the NDA review process.
Advisory Committee Meeting Preparation
We provide support for preparing and conducting advisory committee meetings, including presentation development and rehearsal.
Post-Submission Support
We offer ongoing support to address any questions or requests from regulatory authorities during the NDA review.
Post-Marketing Support
Once your drug is approved and on the market, it is essential to maintain compliance with regulatory requirements and monitor the safety and efficacy of the product. Alta Stomatology provides comprehensive post-marketing support services:
Post-Marketing Surveillance
We establish and manage post-marketing surveillance programs to monitor the safety and effectiveness of your drug.
Regulatory Submissions and Reporting
Our team prepares and submits all required post-marketing reports, including Periodic Safety Update Reports (PSURs) and Annual Reports.
GMP Audits and Compliance
We conduct Good Manufacturing Practice (GMP) audits and provide support to ensure ongoing compliance with manufacturing regulations.
Regulatory Strategy for Lifecycle Management
We help you develop and implement regulatory strategies for lifecycle management, including label expansions, formulation changes, and new indications.
Why Choose Alta Stomatology?
Our team of regulatory affairs experts has decades of experience in the pharmaceutical industry, with a deep understanding of the regulatory requirements for oral disease drugs. We leverage this expertise to provide strategic guidance and practical solutions that help you navigate the complex regulatory landscape with confidence.
Our regulatory support services cover every stage of drug development, from preclinical research to post-market surveillance, offering a holistic approach to regulatory compliance. This comprehensive support streamlines the regulatory process and enhances our ability to meet regulatory requirements efficiently.
Our clients are our top priority. We take client-centered to regulatory support, working closely with you to understand your needs and goals and providing personalized support every step of the way. Our goal is to build long-term partnerships based on trust, transparency, and mutual success.
With experience in navigating the regulatory requirements of multiple countries, we provide global regulatory support to help you achieve market access in key international markets. Our global reach ensures that your drug development program is compliant with the regulations of regulatory authorities worldwide.
For research use only. Not
intended for any clinical use.
