Global Regulatory Affairs and Compliance

Long-term Quality and Regulatory Support

Having an established regulatory strategy early on in a project will be critical to the successful achievement of your marketing objectives. Throughout the years we have developed a straightforward and thorough approach to aligning marketing and regulatory strategies. We look forward to the opportunity to work with your marketing and development teams to determine the most appropriate and feasible route to gaining global market access for your medical device and pharmaceutical products

Regulatory Affairs:

 

United States

We have partnered with clients to bring over 200 Class II medical device 510(k) premarket notification submissions to completion with the finding of substantial equivalence by FDA. The 510(k) process begins with determining your new product’s classification and product code. Frajwtech-regulatoryom there we determine what type of submission is necessary. Some of our other consulting services include Investigational Device Exemptions (IDE) and Pre-Market Approvals (PMA), establishment registrations, device listings, official correspondent and US agent services. Other regulatory application services we provide include both medical device and pharmaceutical products:

To learn more about our in-country representation services here

 

Medical Devices

  • Regulatory Strategy
  • 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)
  • Electronic Common Technical Documentation (eCTD)
  • Facility Registration and Drug Listing
  • FDA Labeler Code Acquisition
  • Drug Master File (DMF)
  • In-country representation and associated regulatory submissions

 

Europe and Canada

ajwtech-regulatory-europeWhen your firm is ready to expand your product lines to the European Union and Canada we can prepare all the necessary technical documentation to achieve both CE Mark and Canadian Device License. Device classifications are different in these regions from FDA requirements and as such the documentation requirements are different.
Our team has extensive experience dealing with the Medical Device Directives (MDD, AIMD and IVD) and Canadian Medical Devices Conformity Assessment System (CMDCAS) requirements, having assisted clients in gaining market clearance in both Europe and Canada.

To learn more about our in-country representation services here

 

Australia and New Zealand

ajwtech-regulatory-australiaajwtech-regulatory-australiaajwtech-regulatory-new-zealandOur team of consultants is poised to provide TGA ARTG listing applications as well as applications to MEDSAFE through the Web Assisted Notification of Devices (WAND) Database through our offices in Australia and New Zealand. Both countries have harmonized with the European Union device classification process and the regulatory application process is fairly straightforward once you have been granted the CE Mark. We are also able to provide the required Sponsor services as the in-country representative to lodge the necessary applications.

To learn more about our in-country representation services here
 

Global Product Registrations

Through our international offices in the US, Australia, New Zealand, Germany, India and the United Kingdom we are able to provide global providing in-country representation and regulatory agency submissions.  Additionally we have ‘Channel Partners’ providing similar services in Latin America and Asia.

Regulatory Compliance

As with any industry, extenuating circumstances present themselves from time to time in the medical device industry. When unfortunate situations arise we assist with medical device reporting (MDR), vigilance reports, corrections and removals as well as recall management in the U.S., Europe, Canada and elsewhere. We assist in completing FDA adverse event reports and other applicable governmental documents.

Also we provide training in Complaint Management, Adverse Event Reporting and Recalls. The FDA conducts routine inspections of medical device manufacturers within the United States and throughout the world. We assist your organization throughout the inspection process, including preparation of FDA Form 483 and warning letter responses.

It is very important to address all the issues an inspector may bring to your attention during the inspection. The response your organization provides needs to be adequate enough to provide enough evidence to FDA that your firm recognizes, understands, corrects and prevents non-conformances and deficiencies in a timely and effective manner. Our firm has the experience and insight to provide guidance during these times.