RTA

Name

RTA

Legal name

Regulatory and Technical Associates, Inc.

Website

https://regulatoryandtechnicalassociates.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

akta.pro secondary industries

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Regulatory affairs consulting
• Preclinical toxicology evaluation
• 510(k) submission services
• Quality management systems
• FDA agent representation

Headquarters

HQ city

Old Lyme

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory Affairs Consulting Services: RTA provides consulting services for regulatory submissions including INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, PMAs, Food Additive Petitions, and GRAS determinations. Services also include Quality Management System writing and supplier/internal auditing services. Revenue is generated through professional consulting engagements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Regulatory and Technical Associates (RTA) is a consultancy that delivers toxicology evaluation, preclinical drug and medical device development support, Quality Management System (QMS) development and auditing, and regulatory affairs consulting for the FDA and global regulatory bodies. Core deliverables include preparation of INDs, NDAs, CTDs, IDEs, 510(k)s, PMAs, Food Additive Petitions, and GRAS determinations, alongside FDA US Agent representation, acquisition due diligence, and clinical research support.

Product overview

RTA is a consultancy offering a unified portfolio of regulatory and technical services rather than a software platform. The core offerings include Toxicology Consulting, Quality Management System Development and Support, Regulatory Submissions Services (covering INDs, NDAs, CTDs, IDEs, 510(k)s, PMAs, and GRAS determinations), and 510(k) Process Services with a demonstrated 90-day approval timeline. The company also provides Acquisition Due Diligence and Clinical Research Services. A sister company, Allendale IRB, extends the portfolio by offering IRB review services. The integrated service model enables clients to receive end-to-end support from product safety evaluation through regulatory submission and market entry.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Submissions Services Preparation and submission of regulatory filings to the FDA and global regulatory bodies, covering INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, PMAs, Food Additive Petitions, and GRAS determinations for pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum companies.
• Toxicology Consulting Expert toxicology evaluation services for novel and established products, providing insights into potential health risks and supporting product safety assessments for pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum industry clients.
• Quality Management System Development and Support Comprehensive Quality Management System writing services plus supplier and internal auditing services to ensure products meet regulatory requirements and adhere to the highest quality standards throughout the development lifecycle.
• 510(k) Process Services Specialized 510(k) submission support with a demonstrated ability to secure approvals within 90 days of submission, helping medical device clients navigate product development and avoid market entry delays.
• FDA US Agent Services Registration as a US Agent with the FDA for multiple companies, providing regulatory representation and liaison services for FDA submissions and ongoing communications.
• Acquisition Due Diligence Services Trusted advisory services helping clients make informed decisions in mergers and acquisitions, ensuring regulatory risks are mitigated and opportunities are optimized.
• Clinical Research Services Comprehensive clinical research support services to guide clients through the complexities of health research, ensuring compliance, quality, and successful trial execution.
• Allendale IRB (IRB Review Services) IRB review services delivered by RTA's sister company Allendale IRB with a personalized approach, transparent communication, and swift turnaround times, often completing protocol reviews within the same week or same business day.

Quantifiable outcome

• Majority of 510(k) submissions approved within 90 days of submission

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Allendale IRBcoreStrategic or Co-development PartnerAllendale IRB (AIRB) is RTA's sister company that works with research professionals for all their IRB review needs. The partnership provides comprehensive support to clients requiring both regulatory consulting and IRB review services. AIRB is committed to a personalized approach with transparent communication, professionalism, and timeliness, offering swift turnaround times with protocols reviewed and approved within the same week, often the same business day.

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• The Weinberg Group: Independent regulatory and toxicology consultancy with comparable offerings in FDA submission support, QMS, and safety assessment, serving pharma and medical device clients.
• Pharmalex: Specialized regulatory and compliance consulting firm for life sciences, providing regulatory affairs, pharmacovigilance, and quality services overlapping with RTA's core engagements.
• NAMSA: Medical device-focused regulatory, quality, and preclinical testing organization. Closely parallel to RTA's 510(k), PMA, and medical device regulatory workflow with deeper testing lab infrastructure.
• ProPharma Group: Regulatory affairs, clinical research, and quality compliance consultancy serving pharma and medical device sponsors. Direct overlap with RTA's submission-prep, QMS, and audit offerings.

Broad incumbents

• WuXi AppTec: Global preclinical and clinical CRO with significant toxicology and safety assessment operations. Overlaps with RTA's preclinical toxicology evaluation consulting, with much broader lab capacity.
• Charles River Laboratories: Major preclinical CRO with safety assessment, toxicology, and regulatory expertise. Direct overlap with RTA's toxicology evaluation service, though at significantly larger scale with in-house labs.
• ICON plc: Global CRO with regulatory and clinical services, comparable to larger-pharma regulatory submission engagements that RTA also services for smaller and mid-tier sponsors.
• IQVIA: Large global CRO and life-science data firm with regulatory affairs and quality services across FDA, EMA, and PMDA. Operates in the same regulatory-consulting space as RTA but at enterprise scale.
• Medpace: Mid-to-large CRO offering clinical trial execution and regulatory services. Competes with RTA on medical-device and pharma sponsors for integrated regulatory-plus-clinical delivery.
• Parexel International: Global CRO offering full-spectrum regulatory affairs, biostatistics, and clinical operations. Overlaps with RTA in FDA submission support but does not specialize in RTA's women-health or multi-industry boutique focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RTA