Global Regulatory Affairs, QA, and FDA Compliance
About Us
RAQA Regulatory Firm stands out from ordinary FDA consultants because we offer a unique approach. We ‘become’ your contract part-time ’employee,’ tailored to suit your specific needs. This personalised service is what sets us apart from a consulting firm.
We hire RA, QA, and FDA Compliance Specialists for you!
About 30 years ago, one FDA investigator used to inspect medical device firms, drug manufacturers, food processing plants, clinical investigators, and all other establishments the FDA regulates. As technology advances, the investigation gradually shifts toward a specialised field.
With the introduction of the automatic manufacturing process, validations became an integral part of a good manufacturing practice (GMP). For example, sterilisation validation, computer system and software validation, process validation, cleanroom validation, and aseptic filling to name a few. As such, medical devices or drug manufacturing processes became impossible for one FDA investigator to be an expert in every field.
21 CFR & ISO
Furthermore, laws and regulations have caught up with advanced and digital technologies, making requirements, laws, regulations, and global standards so complex that they require specialising education degrees and advanced training. Thus, medical device or drug manufacturers began nationwide searching for regulatory affairs (RA), quality assurance (QA), validation, and compliance specialists.
However, hiring every specialist in every field is economically burdensome for some manufacturers, and contacting an expert consultant whenever they have a question or an issue seems impractical or costly. This is where we come in.
RA & Compliance Role Outsourcing
Nationwide searching, hiring, and retaining proficient regulatory affairs specialists and compliance experts is more complex than it sounds. As such, if you are a start-up medical device or pharmaceutical company in the United States or Europe, you can now outsource all your RA, QA, and Compliance activities to our team of former FDA investigators, compliance officers, and reviewers. This highly efficient solution will save you from crises with all regulatory agencies and the financial burden of maintaining in-house specialists.
Also, if you are in the United Kingdom and EU/EFTA member states or Schengen countries, our Europe Office is in Zurich, Switzerland, so travel expenses are minimal.
Because we are always there for you!
Why Partner with RAQA Regulatory Firm?
Former FDA Investigators
Our RAQA Regulatory Firm is composed of ex-FDA officials, EU officials, and QA experts from around the world. We have the expertise you need when it comes to medical device and drug regulatory and compliance.
Whenever your regulatory specialists or quality staff have questions, it’s frustrating when you are stuck without answers. What’s more? When you have important or time-sensitive issues, but you have nowhere to turn to. No more! We are there for you. We are only your phone call away, emails, on-site visitation, or video conference; we are there for you! With our reasonable monthly plans, you can select a level of the service you need. In most cases, we will answer your questions within 24 hours.
Received a Notice of FDA Inspection?
When you receive notice of inspection from the United States Food and Drug Administration (FDA), and you have never experienced it before, your quality staff can panic or be uncertain about what to do. This is when you make a vital mistake. That’s why we are here! We can train or mock the inspection so your quality team can control the situation. Even one unintentional mishap can cause the FDA inspection to be non-compliant and jeopardize your company. Trying to fix them after is costly and time-consuming. It’s best to avoid any “uneducated,” “unintentional” mistakes by partnering with RAQA Regulatory Firm, ensuring the compliance of your manufacturing operations.
Perks of Partnership
For additional low costs with no or minimal travel costs, the benefits of being a partner with RAQA Advisors are:
-
- Regulatory Submissions Preparation
- Conduct Mock FDA Inspection
- Perform Vendor Audits and Qualifications
- On-Site FDA Inspection Assistance
- On-Site Training
What's more?
With RAQA Regulatory Firm, you can avoid the hefty international travel costs in Europe, the UK, Switzerland, or South Korea. Our services are designed to be financially feasible, with you only needing to cover local travel costs or overnight stays when you request on-site visitation. This cost-effectiveness ensures that our partnership is both reliable and wise.
Managing Director & Founder
Andrew Young
Managing Director & Founder
Andrew began his career with the US FDA right after college. He has a wealth of experience in government and private industries around the world, giving him a comprehensive understanding of diverse regulatory environments. He has been on both sides of the table. As an FDA Investigator, he inspected the new start-up companies to the world’s largest medical device and drug manufacturers. He issued countless FDA Form-483, Inspectional Observations, at the end of the inspection to document deficiencies and deviations. As a Compliance Officer, he issued numerous warning letters (WL) and official legal actions to the violators of the FDA laws and regulations, including international manufacturers. As a Principal Auditor, he has conducted mock FDA inspections of large and small manufacturers in China, South Korea, Europe, and the United States. His successful authorship of regulatory submissions on behalf of manufacturers further underscores his global expertise.
Qualifications
CV & Expertise
- Managing Director
- Principal Auditor, Mock FDA Inspection
- Regulatory Affairs, FDA Consultant
- Ex-FDA Supervisory Investigator (SCSO)
- Ex-FDA Senior Compliance Officer
- Ex-FDA Medical Device Investigator
- Ex-FDA Foreign Inspection, Medical Device Cadre
- Former Lieutenant Commander, US PHS
Expertise:
- Mock FDA Inspection
- 21 CFR 820, 211
- CAPA
- Warning Letter & FDA-483 Responses
- Medical Device Regulation (MDR)
- ISO 13485
- 510(k), PMA Submissions
- NDA, ANDA Submissions
- Quality Assurance
- CE Marking
Flexible and Convenicence Plan
Partnership Plan
Low Risk 100
Ideal for well-established, experienced manufacturers and distributors, and low-risk products for compliance and regulatory support.
Include eight (8) hours of consulting by phone, email, video, and mail correspondence per month.
Start Up 200
Ideal for start-up companies that need training and consulting in regulatory submissions and quality assurance.
Include twelve (12) hours of consulting per month. This can substitute for one day of on-site* visitation.
Medium Risk 300
The most popular plan involves well-established, medium-risk processes—ideally, Class II (not-sterile) or OTC drug manufacturers and specification developers.
Include 20 hours of consulting per month. This can substitute for two consecutive days of on-site* visitation.
High Risk 400
Manufacturers with high-risk processes (sterile, WFI, aseptic, or validation) or products requiring approval, pre-market or post-market surveillance.
Include 40 hours of consulting per month. This can substitute for four consecutive days of on-site* visitation.
NOTE
Non-visitation, virtual consulting is performed by phone, email, video, and mail correspondence by appointment or with advance notice. • A priority will be given to high-risk or on-site inspection assistance. • Additional hours are available and will be billed separately. • *Travel expenses may incur depending on the site location.
Connect with Us
We are there for you—we are only a phone call away! Unlock your business’s potential by partnering with RAQA Regulatory Firm, former FDA and EU officials. Reach out to discover how we can guide your regulatory and compliance strategies.