J&J Consulting Group- FDA Regulatory Compliance
- 1101 California Ave Suite 100 Corona CA 92881
- Info@jjccgroup.org
- (800) 999-7781
JJCC Group helps FDA-regulated companies build compliant systems, file clean submissions and pass inspections
Book a Call With a Senior FDA Expert
Facing an FDA inspection, 483, submission, or new product launch? Get clear guidance from a senior compliance expert.
Dietary Supplements:
Part 111 cGMP, labeling and claims, NDI notifications, FSVP for imported ingredients.
About JJCC Group
Regulatory Consulting Services
JJCC delivers expert regulatory consulting services built on 30+ years of FDA compliance experience. We help drug, medical device, dietary supplement, tobacco/e-liquid, and food and beverage companies launch safely, manage risk, and stay ahead of changing regulations — all through one streamlined, affordable consulting partner.
From product development through regulatory submissions, JJCC is your gateway to compliant, market-ready products and long-term business growth.
Build a compliant system
cGMP compliance, QMS implementation, ISO 13485, ISO 9001, risk management
Get inspection-ready
FDA mock audits, quality audits, MDSAP preparedness, Form 483 and Warning Letter response
Guiding Your Products
Expert ISO 9001 Consulting Services
Achieving ISO 9001 certification is more than a quality badge — it’s a strategic investment in operational excellence, customer trust, and long-term business growth. As an experienced ISO consultant, JJCC helps organizations design, implement, and maintain a robust Quality Management System (QMS) that aligns with ISO 9001:2015 standards. From initial gap analysis and documentation development to internal audits and certification readiness, our consultants guide you through every step of the process. Whether you’re a startup pursuing certification for the first time or an established company seeking recertification, our tailored ISO 9001 consulting services streamline compliance, reduce costly errors, and accelerate your path to certification.
Medical devices
the QMSR took effect Feb 2, 2026. Part 820 now incorporates ISO 13485:2016 by reference, and FDA inspects to it.
Quality systems
ISO 9001:2026 is being published this fall and will replace ISO 9001:2015 after a transition period.
Submission for medical devices
Expert Compliance
ISO 13485 For Medical Device Manufacturers
With over 30 years of regulatory expertise in the medical device industry, JJCC Group is the partner of choice for companies that demand both technical precision and practical, business-minded consulting. Our ISO 13485 consultants bring deep knowledge of FDA 21 CFR Part 820, EU MDR, MDSAP, and harmonized international requirements, ensuring your QMS supports not only ISO 13485 certification but also broader global compliance goals. From initial implementation and internal audits to supplier qualification, CAPA management, and post-market surveillance, we provide end-to-end support that strengthens product quality, patient safety, and regulatory confidence. Partner with JJCC Group to turn ISO 13485 compliance into a competitive advantage that drives growth, reduces risk, and builds lasting trust with regulators and customers worldwide.
Open Hours
Mon-Fri : 10am-5pm
100%
Happy Client
Our Industries
Industries we serve
As one of the leading regulatory affairs consulting firms, JJCC provides expert regulatory and compliance solutions across a wide range of industries, helping businesses navigate complex regulations and bring safe, high-quality products to market. The services offered by JJCC specialize in many common product categories:
Companies within the product development space are invited to book a consultation today. Speak with us to learn how JJCC can streamline your regulatory consulting through modern and tailored regulatory compliance consulting.
Compliance Made Simple
Simplifying Compliance, Accelerating Success
JJCC delivers expert regulatory guidance and regulatory compliance solutions across multiple industries, ensuring your products meet global standards and reach the market safely.
Free 30–45 minute call
We learn your product, your market and your deadline.
Gap assessment
We compare what you have with what FDA expects, citation by citation.
Roadmap and remediation
3.We write the SOPs, forms, validations and submissions, or coach your team to do it.
Inspection or submission support
We stay with you through FDA review, inspection or response.
Sustain
We train your staff through The cGMP Academy so compliance holds after we leave.
FDA Mock inspection
FDA Warning Letter (Form 483) Resolution
Product and Customer Complaints
Partner with JJCC Group
The Most Trusted Regulatory Consulting Firm
Think of us as your on-demand regulatory affairs consulting firm. We assess, mitigate, and manage your risk to reduce your liability, streamline your product development and production, and bring your FDA-regulated product vision to life.
Each consulting client we take on enjoys a regulatory compliance solution tailored to their unique product, industry, business scale, and challenges. We offer:
Founder-led
Mike Khalil has spent 37 years in FDA-regulated industries and personally leads every engagement.
Operators, not just advisors
Our leadership has run companies as President, CFO and COO. We know a fix has to work on the floor and on the budget.
One multidisciplinary team
Scientists, toxicologists, regulatory specialists, quality professionals and medical writers under one roof.
Engage Through Video
Showcase your story, products, or expertise
Use single videos, background clips, or a full video gallery to captivate your audience and highlight your brand, products, or services effectively.
With high definition videography, professionally shot and edited per your audience expectations, you can drive interest in a fully compliant manner.
Our professional video solutions are offered in tandem with our consulting services and are designed to help inform, entertain, and move the needle—all squarely within industry guidelines and best practices.
Our Journey on Screen
Inspire and Inform
Expertise in Action
Our Story Unfold
Testimonials
What our client say about us
Hear from our clients how JJCC’s expert regulatory and scientific support has helped them achieve compliance, streamline processes, and successfully bring their products to market.
NutraLife Supplements
JJCC guided us through our first FDA approval seamlessly. Their expertise made the entire process smooth and stress-free.
Eric Thompson
CEO
Global Pharma Inc
The team’s regulatory and scientific support was invaluable. JJCC ensured our products met all compliance standards efficiently.
Mark Rivera
Product Manager
Vital Health Labs
JJCC’s expert guidance helped us streamline operations and maintain top-quality standards across our product line.
Emily Chen
Director of Quality
GreenVape Co.
From regulatory submissions to manufacturing support, JJCC has been a trusted partner at every stage of our growth.
David Patel
Founder
BioCare Solutions
Their team’s dedication and knowledge ensured our products complied with global regulations—saving us time and effort.
Laura Martinez
Head of Regulatory
Wellness Innovations
JJCC’s comprehensive support gave us confidence in our product launches, helping us thrive in a competitive industry.
James Wilson
COO Founder
Contact Us
Get in touch with us
Fill out the form below so we can better understand your business and objectives. One of our regulatory compliance experts will be in touch to outline our range of services and explain how we can enhance your enterprise.
Benefits:
- Expert Guidance
- End-to-End Support
- Compliance Assurance
- Time & Cost Efficiency
Contact info:
- Info@jjccgroup.org
- 1 (800) 999- 7781
- 1101 California Ave Suite 100 Corona CA 92881
Faws
Frequently asked questions
Want to know more about our expert regulatory consultant solutions? Find answers to common questions about JJCC’s regulatory, scientific, and compliance services.
A compliance consultant helps you meet FDA rules for your product and facility. That covers gap assessments, quality systems, SOPs, submissions, labeling reviews, mock inspections and responses to FDA findings.
We serve six FDA-regulated industries: dietary supplements, drugs and biologics, medical devices, food and beverage, cosmetics, and tobacco and vape products. Many clients sell in more than one category, and we cover all of them.
Yes. We prepare first-time PMTAs, 510(k)s, NDI notifications, GRAS notices, cosmetic registrations and listings, and drug establishment registrations. We start by confirming which pathway your product needs.
No. FDA approves drugs, biologics, high-risk (PMA) devices and color additives. It clears 510(k) devices, issues marketing orders for tobacco, and does not approve cosmetics, supplements or most foods before sale.
Cost depends on scope, product type and how much already exists. After a free call, we give a fixed-fee quote for defined work or a retainer for ongoing support.
A focused, well-documented operation can be ready in 3 to 6 months. A startup or multi-line facility building from scratch usually needs 6 to 12 months or more.
Yes. Many clients are founders launching their first product. We scale the system to your size, so you are not buying paperwork you do not need.
Yes. We draft the response, build the CAPA plan and verify the fixes. FDA reviews 483 responses received within 15 business days before it decides on further action, so call us early.
Yes. We support EU TPD and UK tobacco notifications, Health Canada, MDSAP countries (Australia, Brazil, Canada, Japan and the U.S.), and EU and international supplement rules.
Both. Gap assessments, audits and mock inspections are usually on-site. Document work, submissions and training can be remote.
Yes. We sign a mutual NDA before we see any documents, and every deliverable is treated as confidential.
Mike Khalil leads every engagement. Toxicologists, scientists, regulatory specialists and writers join as your project needs them.
Yes. Our training arm, The cGMP Academy, offers FDA regulation training by CFR part, plus custom on-site training for your staff.
The QMSR took effect Feb 2, 2026. Part 820 now incorporates ISO 13485:2016, and FDA replaced its old QSIT inspection approach. See our Medical Devices page.The QMSR took effect Feb 2, 2026. Part 820 now incorporates ISO 13485:2016, and FDA replaced its old QSIT inspection approach. See our Medical Devices page.
We are at 1101 California Ave, Suite 100, Corona, CA 92881. We serve clients across the U.S. and internationally.
Book a free consultation online or call (800) 999-7781, Monday to Friday, 10 am to 5 pm Pacific.
