DTS Regulatory Consultants
DTS is a Service-Disabled Veteran-Owned Small Business (SDVOSB) specializing in federal-ready cybersecurity and CMMC compliance for government contractors. They offer tailored solutions for secure, compliant, and operational readiness.
DTS Regulatory Consultants is a Service-Disabled Veteran-Owned Small Business (SDVOSB) founded in 2011, dedicated to providing federal-ready cybersecurity and CMMC compliance solutions. With over a decade of experience supporting federal agencies and the Defense Industrial Base, DTS combines cybersecurity authority with contracting credibility. They offer a comprehensive suite of services including GAP Analysis, Remediation, MSSP Services, Compliance Support, and Federal Services, ensuring clients achieve secure, compliant, and operational readiness. DTS is recognized for its proven outcomes, validated by C3PAO and DIBCAC assessors, and provides customized compliance solutions tailored to client environments. Their leadership team brings extensive military service, cybersecurity expertise, and federal contracting experience, operating with a mission-first mindset. DTS holds enterprise-level CMMC Level 2 certification and ISO 27001 ISMS certification, demonstrating their commitment to the highest security and compliance standards. They are a trusted partner for businesses and agencies seeking to navigate complex federal requirements and strengthen their security posture.
About
**Who they are**
DTS Regulatory Consultants is a Service-Disabled Veteran-Owned Small Business specializing in federal-ready cybersecurity and CMMC compliance for government contractors.
**Expertise & scope**
* Tailored solutions for secure, compliant, and operational readiness.
* Focus on cybersecurity and CMMC compliance.
**Reputation / proof points**
* Service-Disabled Veteran-Owned Small Business (SDVOSB) status.
DTS Regulatory Consultants is a Service-Disabled Veteran-Owned Small Business specializing in federal-ready cybersecurity and CMMC compliance for government contractors.
**Expertise & scope**
* Tailored solutions for secure, compliant, and operational readiness.
* Focus on cybersecurity and CMMC compliance.
**Reputation / proof points**
* Service-Disabled Veteran-Owned Small Business (SDVOSB) status.
Additional information
DTS Regulatory Consultants focuses on providing tailored solutions to meet the specific needs of government contractors requiring cybersecurity and CMMC compliance. Their approach emphasizes ensuring clients are operationally ready and compliant with federal requirements. Engagement typically involves understanding the client's current security posture and developing a roadmap to achieve and maintain necessary certifications.
Key Highlights
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Specializes in navigating Australian regulations for Therapeutic Goods (TGA) and Agricultural/Veterinary products (APVMA).
Source
“Therapeutic Medicines are regulated by the TGA (Aust) and Medsafe (NZ). Medical Devices are regulated by the TGA (Aust) and Medsafe (NZ).”
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Offers services including product development, product import, and GMP compliance.
Source
“ServicesAgriculture & VeterinaryTherapeuticsComplementary MedicinesBiostimulantsMedical DevicesCosmeticsActive ConstituentIndustrial Chemical (AICIS)Software as a Medical DeviceProduct DevelopmentProduct ImportGMP Compliance”
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Provides expert guidance for TGA pre-market assessments, ensuring safety, efficacy, and quality standards are met.
Source
“The TGA’s pre-market assessment ensures that therapeutic goods, including medicines, medical devices, and blood products, adhere to stringent standards for safety, efficacy, and quality.”
Certifications & Trust Signals
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Operates with a philosophy of honesty and authenticity, aiming for 'Right First Time' outcomes.
Source
“HonestyWe say what we mean and we do what we say. AuthenticityWe strive to make all our work “Right First Time” but sometimes things don’t go according to plan.”
Buyer Snapshot
Best for
- Australian TGA regulatory submissions for medicines and medical devices
- Navigating APVMA regulations for agricultural and veterinary products
- Companies seeking GMP compliance and product development support
How engagement typically works
- Collaborative problem-solving
- Close work with clients and regulators
- Team-based project approach
Typical deliverables
- Regulatory strategy and guidance
- Product registration support
- GMP compliance advice
- TGA pre-market assessment support
Good to know
- Best when clients require specialized expertise in Australian therapeutic goods and agricultural/veterinary regulations.
HQ:
ARLINGTON, US
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Hospital equipment, Consumables, Medical devices
Portfolio:
1-5
Onboarding time:
5–30 days
Pricing model:
Per project
Starting from:
AUD 5,000
Included services:
Annual ARTG charge reminders and continuity planning, Conformity assessment evidence mapping (EU/UK/US/CA), Change notification and variation assessment, TGA device classification and grouping
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Australian Entity State:
Queensland
Additional tga_sponsor_au Details
Supports Artg
Yes
Recall Vigilance Support
Yes
Australian Entity State
Queensland
