Regulatory Affairs Services
Your Global Partner for Medical Device & Pharmaceutical Compliance.
Establishing regulatory strategy early is critical to achieving your marketing objectives. We’ve developed a straightforward approach to aligning marketing and regulatory strategies, working with your teams to determine the most feasible route to global market access.
AJW Technology Consultants provides regulatory affairs and quality system consultation for medical device, IVD, pharmaceutical, and cosmetic manufacturers.
With offices across the US, Germany, UK, Switzerland, Australia, and New Zealand (plus Channel Partners in Latin America and Asia), we serve as your outsourced regulatory partner, providing experienced expertise as an extension of your team.
Strategic Regulatory Planning
Establishing the right regulatory pathway before investing saves time, resources, and prevents costly missteps. Our planning services include feasibility assessments, strategy development, pre-submission meetings, gap assessments across regions, technical documentation review, and global submission support.
United States
FDA Medical Device & Pharmaceutical Submissions.
Establishing the right regulatory pathway before investing saves time, resources, and prevents costly missteps. Our planning services include feasibility assessments, strategy development, pre-submission meetings, gap assessments across regions, technical documentation review, and global submission support.
Medical Devices
We’ve completed over 200 successful Class II 510(k) submissions with FDA substantial equivalence findings. The process begins with determining your product’s classification, product code, and appropriate submission type.
Learn more about our in-country representation services
Learn more about our drug establishment registration and listing services
Medical device regulatory services
- Regulatory strategy
- FDA Presubmission Meetings
- 510(k) Premarket Notification
- Premarket Approval (PMA)
- Investigational Device Exemption (IDE)
- Automatic Class III Designation (De Novo)
- FDA Establishment Registration and Device Listing
- In-country representation and associated regulatory submissions
Pharmaceuticals
- Regulatory Strategy
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- In-country representation and associated regulatory submissions
- Electronic Common Technical Document (eCTD)
- Facility Registration and Drug Listing
- FDA Labeler Code Acquisition
- Drug Master File (DMF)
Europe
CE Marking and MDR/IVDR Compliance.
When expanding to the European Union, we prepare all necessary technical documentation for CE Mark. Device classifications and documentation requirements differ from FDA standards. Our team has extensive experience with Medical Device Directives (MDD, AIMD, IVD) and current MDR and IVDR regulations.
- Regulatory strategy and pathway determination
- Technical documentation preparation
- In-country representation and associated regulatory submissions
- Regulatory submission support (MDR, IVDR)
- CE marking consultation
United Kingdom
UKCA Marking and UK Responsible Person Services.
Following Brexit, all medical device manufacturers marketing in the UK must appoint a UK Responsible Person (UKRP). Our London office supports device registration requirements and serves as your UKRP and correspondent with MHRA.
- UKCA marking and regulatory strategy
- Technical documentation support
- UK Responsible Person (UKRP) services
- MHRA correspondence and regulatory submissions
- Post-market compliance support
Switzerland
Authorized Representative and SwissMedic Services.
Since May 26, 2021, Switzerland requires in-country authorized representatives (AR). Our Zurich office (a registered branch of our Germany office) provides Swiss AR and product registration services. While only some devices require registration, all devices regardless of classification require Swiss AR appointment.
- SwissMedic product registration
- Swiss Authorized Representative (AR) appointment
- Technical documentation support
- Regulatory submission support
- Post-market compliance
Canada
Medical Device License and Health Canada Submissions.
When expanding to Canada, we prepare all necessary technical documentation for Canadian Device License. Device classifications and documentation requirements differ from FDA standards. Our team has extensive experience with Canadian Medical Devices Conformity Assessment System (CMDCAS) requirements and market clearance.
- Regulatory strategy
- Medical Device License applications
- Technical documentation preparation
- Regulatory correspondent and associated regulatory submissions
Australia and New Zealand
TGA and Medsafe Market Access.
Our Australia and New Zealand offices provide TGA ARTG listing applications and Medsafe WAND Database submissions. Both countries have harmonized with EU device classifications, streamlining the process for CE-marked devices. We provide required Sponsor services as your in-country representative.
- TGA ARTG listing applications (Australia)
- Medsafe WAND Database submissions (New Zealand)
- Device classification and regulatory strategy
- Sponsor services and in-country representation
- Regulatory submission support
Regulatory Compliance & FDA Inspections
We assist with medical device reporting (MDR), vigilance reports, corrections, removals, and recall management across the U.S., Europe, Canada, and globally. We provide training in Complaint Management, Adverse Event Reporting, and Recalls.
The FDA conducts routine inspections of medical device manufacturers worldwide. We assist throughout the inspection process, including FDA Form 483 and warning letter response preparation. Your response must provide adequate evidence that your firm effectively recognizes, understands, corrects, and prevents non-conformances.
Why Work With AJW?
Customers often lack in-house regulatory and quality expertise, forcing teams beyond their experience. We eliminate the need for full-time specialists while providing consistent, senior-level support when needed.