RTA
Regulatory and Technical Associates, Inc. (RTA) is a distinguished consultancy specializing in toxicology, preclinical drug and medical device development, Quality Management System Development and Support, and Regulatory Affairs. The company boasts a team of board-certified experts with extensive experience, serving both domestic and international clients across industries such as pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum. RTA is recognized as a foremost authority in women's health and holds registration as a US Agent with the FDA for multiple companies. Its mission is to evaluate the safety of products and assist clients in navigating complex regulatory landscapes, preparing submissions for FDA and global regulatory bodies, and securing approvals efficiently.
Industries
Nr. of Employees
small (1-50)
RTA
Old Lyme, Connecticut, United States, North America
Products
Toxicology and Preclinical Consulting
Consulting services specializing in toxicology, preclinical drug and medical device development, and safety evaluation of novel and established products.
Quality Management System Development and Support
Comprehensive quality management system writing services, supplier and internal auditing services, and quality assurance consulting.
Regulatory Affairs Services
Preparation of regulatory submissions for the FDA and other global regulatory bodies including INDs, IDEs, 510(k)s, and PMAs.
Allendale IRB Review Services
Institutional Review Board (IRB) review services for research professionals offering personalized approach, transparent communication, and swift turnaround times.
Toxicology and Preclinical Consulting
Consulting services specializing in toxicology, preclinical drug and medical device development, and safety evaluation of novel and established products.
Quality Management System Development and Support
Comprehensive quality management system writing services, supplier and internal auditing services, and quality assurance consulting.
Regulatory Affairs Services
Preparation of regulatory submissions for the FDA and other global regulatory bodies including INDs, IDEs, 510(k)s, and PMAs.
Allendale IRB Review Services
Institutional Review Board (IRB) review services for research professionals offering personalized approach, transparent communication, and swift turnaround times.
Services
Consulting on toxicology study design, safety assessment, and interpretation for pharmaceutical, medical device, cosmetic, food, and chemical products.
End-to-end preparation and management of regulatory dossiers for FDA and other global authorities, including INDs, NDAs, CTDs, IDEs, 510(k)s, PMAs, and related filings.
Development and writing of QMS documentation and provision of supplier and internal auditing services to support compliance and quality objectives.
Due diligence assessments focused on regulatory, quality, and safety liabilities to inform mergers and acquisitions.
Coordination with institutional review board services for expedited protocol review and ethical oversight support for clinical research.
Consulting on toxicology study design, safety assessment, and interpretation for pharmaceutical, medical device, cosmetic, food, and chemical products.
End-to-end preparation and management of regulatory dossiers for FDA and other global authorities, including INDs, NDAs, CTDs, IDEs, 510(k)s, PMAs, and related filings.
Development and writing of QMS documentation and provision of supplier and internal auditing services to support compliance and quality objectives.
Due diligence assessments focused on regulatory, quality, and safety liabilities to inform mergers and acquisitions.
Coordination with institutional review board services for expedited protocol review and ethical oversight support for clinical research.
Expertise Areas
- Toxicology and preclinical safety assessment
- Preclinical drug and medical device development
- Regulatory affairs and submission strategy
- Quality management systems (QMS) development
Key Technologies
- Preclinical toxicology assessment methods
- Regulatory submission frameworks (IND, NDA, CTD, IDE, 510(k), PMA)
- Quality management system frameworks and auditing
- IRB protocol review and human-subjects ethics processes