AcKnowledge Regulatory Strategies
AcKnowledge Regulatory Strategies is a privately held, boutique regulatory affairs consultancy founded in 2014 in San Diego, with 1-10 employees serving medical device and in vitro diagnostics industry clients.
- Company typePrivate
- Founded2014
- HeadquartersSan Diego, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What AcKnowledge Regulatory Strategies does
AcKnowledge Regulatory Strategies is a privately held, for-profit firm headquartered in San Diego, California, founded in 2014. The firm operates as a small boutique consultancy with 1-10 employees that specializes in regulatory affairs consulting for the medical device and in vitro diagnostics (IVD) industry. The company's stated focus is guiding medical device and IVD clients through regulatory compliance, submissions, and related quality matters, operating primarily through its website at acknowledge-rs.com.
The business model is consistent with a professional services consultancy: client engagements are project-based or retainer consulting work in regulatory affairs, with no publicly disclosed pricing, product platform, technology stack, or subscription offering. The firm is privately held with no disclosed funding rounds, ownership structure, or institutional investors, and there is no public ticker or exchange listing.
Beyond the firmographic metadata, the input provides no information on customer composition, named logos, product portfolio detail, revenue, leadership team, partnerships, awards, geographic footprint beyond San Diego, or go-to-market motion. The firm appears to operate as a low-visibility niche consultancy with no public signaling of scale, customers, or strategic direction, indicating that the company's market presence and competitive position cannot be assessed from the available evidence.
AcKnowledge Regulatory Strategies firmographics
Firmographics- Name
- AcKnowledge Regulatory Strategies
- Legal name
- RQM+
- Website
- https://acknowledge-rs.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- AcKnowledge Regulatory Strategies is a privately held, boutique regulatory affairs consultancy founded in 2014 in San Diego, with 1-10 employees serving medical device and in vitro diagnostics industry clients.
- Ownership category
- akta.pro rank
AcKnowledge Regulatory Strategies industry classification
Industry- Product category
- Regulatory Affairs Consulting
- NAICS
- Management Consulting Services (54161)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)
Keywords
Where AcKnowledge Regulatory Strategies is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
AcKnowledge Regulatory Strategies business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales
Revenue model
- Regulatory & Quality Consulting: Consulting services guiding clients through regulatory challenges, compliance, and quality assurance for medical devices, IVDs, and combination products from concept to market.
- Clinical Trials Management: End-to-end clinical trial management services keeping trials efficient, safe, and compliant.
- Laboratory & Material Science Services (Jordi Labs): FDA-recognized laboratory testing and material science services including chemical characterization, extractables/leachables, and biocompatibility testing.
- Reimbursement Strategy: Reimbursement strategy services helping MedTech products succeed commercially in the market.
- Staff Augmentation / Professional Staffing: On-demand MedTech professionals, functional service support, fast deployment, and contract-to-hire options integrated with client teams.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels6 records
AcKnowledge Regulatory Strategies product offering
Product offeringCore offering
AcKnowledge Regulatory Strategies is a San Diego-based regulatory affairs consulting firm founded in 2014 that serves the medical device and in vitro diagnostics (IVD) industry. The firm provides specialized regulatory affairs consulting services tailored to medical device and IVD manufacturers requiring support with FDA pathways, submissions, and compliance. With a headcount of 1-10 employees, the firm operates as a focused boutique consultancy serving the MedTech regulatory market.
Product overview
RQM+ is a full-service MedTech Contract Research Organization (CRO) offering a unified portfolio of four core services — Regulatory & Quality, Clinical Trials, Lab & Material Science (delivered via Jordi Labs), and Reimbursement — that collectively guide MedTech products from concept through post-market. These services are supplemented by three flexible partnering models (Outsourcing, Professional Consulting, and Staff Augmentation) and specialized therapeutic area expertise across Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, Companion Diagnostics, and Emerging MedTech & Startups. In March 2026, RQM+ launched SMART Solutions, a life-cycle partnership model designed to provide integrated end-to-end support. The company also operates proprietary technology platforms that drive a claimed 50% efficiency gain for clients.
Differentiator
Problem solved
Functional benefit
Brands
- Jordi Labs: Industry-leading materials testing and chemical characterization lab services, recognized by the FDA.
Quantifiable outcome
- 50% efficiency gain through proprietary technology platforms
- +3 more outcomes
Companies that use AcKnowledge Regulatory Strategies
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles1 record
AcKnowledge Regulatory Strategies technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
AcKnowledge Regulatory Strategies partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Jordi LabscoreJordi Labs is a specialized materials testing and chemical characterization laboratory acquired by or integrated into RQM+. It provides gold-standard, FDA-recognized lab services including extractables/leachables, biocompatibility, and material science testing. Jordi Labs is a core component of RQM+'s service offering and a key differentiator.
Scale indicators6 records
AcKnowledge Regulatory Strategies competitors and assessment
Company assessmentBroad incumbents
- IQVIA: A global CRO and life sciences services firm with regulatory affairs, clinical, and technology capabilities including medical device work. Represents the scaled end of the regulatory services market against which boutique firms like AcKnowledge RS compete.
- TÜV SÜD: A global notified body and testing organization offering medical device certification, regulatory compliance, and quality management services. Represents a large incumbent in the regulatory services space adjacent to AcKnowledge RS's niche.
- Parexel International: A global CRO with regulatory, clinical, and consulting services spanning pharma, biotech, and medical devices. Overlaps with AcKnowledge RS in medical device regulatory consulting but as part of a much broader full-service portfolio.
- BSI (British Standards Institution): A notified body and standards organization providing CE marking, ISO 13485 certification, and regulatory advisory services for medical devices. Operates in the adjacent regulatory ecosystem that AcKnowledge RS's clients must navigate.
Emerging players
- Greenlight Guru: A MedTech-focused quality management and regulatory workflow software platform. While primarily software rather than consulting, it represents an adjacent value proposition for medical device regulatory and quality operations that competes for client budget.
Direct peers
- MethodSense: A regulatory affairs and quality compliance consulting firm focused on medical devices, IVDs, and combination products. Like AcKnowledge RS, MethodSense is a boutique specialist in regulatory strategy and submissions, making it a close head-to-head peer.
- Medical Device Regulatory Solutions (MDRS): A boutique consulting firm providing regulatory affairs, quality systems, and clinical trial services for medical device and IVD companies. Operates in the same niche as AcKnowledge RS with comparable service offerings.
- NAMSA: A medical device-focused CRO providing regulatory, clinical, and laboratory testing services. NAMSA competes in the same regulatory consulting space as AcKnowledge RS but with substantially broader global lab and clinical capabilities.
- RQM+: A full-service MedTech CRO offering regulatory and quality consulting, clinical trials, FDA-recognized lab services via Jordi Labs, and reimbursement strategy for medical device, IVD, combination product, and CDx manufacturers. It is the most directly comparable scaled competitor to AcKnowledge RS in the medical device/IVD regulatory niche.
- RCRI (Regulatory & Clinical Research Institute): A Minneapolis-based medical device regulatory and clinical research consultancy offering regulatory submissions, clinical trial management, and quality system support. Comparable to AcKnowledge RS as a mid-sized medical device regulatory specialist.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat1 record
Key risks5 records
Key highlights4 records
Customer concentration
AcKnowledge Regulatory Strategies social profiles
Digital presenceAcKnowledge Regulatory Strategies compliance and trust
Trust signalCompliance2 records
AcKnowledge Regulatory Strategies financial estimates
Financial estimateRevenue estimate
Valuation estimate
AcKnowledge Regulatory Strategies leadership team
Management profileNumber of profiles
AcKnowledge Regulatory Strategies funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
AcKnowledge Regulatory Strategies M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about AcKnowledge Regulatory Strategies
What does AcKnowledge Regulatory Strategies do?
AcKnowledge Regulatory Strategies is a San Diego-based regulatory affairs consulting firm founded in 2014 that serves the medical device and in vitro diagnostics (IVD) industry. The firm provides specialized regulatory affairs consulting services tailored to medical device and IVD manufacturers requiring support with FDA pathways, submissions, and compliance. With a headcount of 1-10 employees, the firm operates as a focused boutique consultancy serving the MedTech regulatory market.
Is AcKnowledge Regulatory Strategies a public or private company?
AcKnowledge Regulatory Strategies is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was AcKnowledge Regulatory Strategies founded?
AcKnowledge Regulatory Strategies was founded in 2014. It employs 1 to 10 people.
Where is AcKnowledge Regulatory Strategies based?
AcKnowledge Regulatory Strategies is headquartered in San Diego, United States, in the North America region.
How does AcKnowledge Regulatory Strategies make money?
Five revenue lines are on record. Regulatory & Quality Consulting is the primary driver. The others are clinical Trials Management, laboratory & Material Science Services (Jordi Labs), reimbursement Strategy and staff Augmentation / Professional Staffing.
Who are AcKnowledge Regulatory Strategies's main competitors?
Broad incumbents on record are IQVIA, TÜV SÜD, Parexel International and BSI (British Standards Institution). Greenlight Guru is listed as an emerging player. Direct peers are MethodSense, Medical Device Regulatory Solutions (MDRS), NAMSA, RQM+ and RCRI (Regulatory & Clinical Research Institute).
Does AcKnowledge Regulatory Strategies have an API?
No public API is recorded for AcKnowledge Regulatory Strategies.
What industry is AcKnowledge Regulatory Strategies in?
AcKnowledge Regulatory Strategies's product category is Regulatory Affairs Consulting. Its primary akta.pro industry code is HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management). Its NAICS code is 54161 and its SIC code is 8742.