Everything you need to know about FDA regulatory consulting

Everything you need to know about FDA regulatory consulting

Most of those manufacturers of medical device having customer base outside India and specifically if in USA, must know about FDA regulations and ever-changing additions and deletions to that. If some thing is not taken care due to lack of knowledge, late knowledge, or appropriate knowledge, it becomes very expensive affair for the firm including closure of business, depending on the criticality of the issue.

Bigger firms having wide business in USA and Europe normally employ experienced and expert regulatory person on their role to take care of regulatory affairs on day-to-day basis and to resolve issues when they arise.

However, it is still sometime some complex issue emerge due to 483 or warning letters or some regulation change and its impact on medical devices which are already in the market, may be very high. In such situation firm’s inhouse resource, may not be so useful and some outside consultancy may be required.

How do we select US FDA consulting firms which can be useful to us? There are very specific jobs are done by some US FDA Consulting firms or rather they are being known as specialists in that field.

Before looking at USFDA consulting firms, one must be sure as to what is that one is looking for and it’s advisable that document the same in detail and prioritise. This will help selecting consultancy firms and consultancy firms will have better understanding of your problem or your objective of hiring them.

What is generally expected from US FDA consultancy firms?Generally, they provide general regulatory advice and strategy service say for medical device business such as, 1. They guide about applicable requirement to your business, like type of medical device one manufacture and based on class and critical features of device.

2. Advice on strategic front on development or coming regulations and submission preparation 3. On call communication for clarification and support.

4. US FDA consultancy firms are active in information gathering on world front. Then they can provide regular information if that concerns to one’s product.

5. Provide information on real-time notices published and impact if any, what action, if needed.

6. If your scope is wide and generic then they can advice and support on compliance assurance process.

7. They can provide service on validating waiver request and read-across arguments.

8. They support regulatory and research Q&A style.

9. If in scope, they provide product safety and efficacy evaluations as they are also accessible of similar products published information.

10. If needed, they can help in conducting human health and environmental risk assessment and guide us about unique threats possible.

11. Third party technical liaison if in the scope.

With all above services in place, 483, warning letters or product recall should not happen but in case it happens, the hired firms support you to come out of it and keep you always in compliance by suitably handling this issue.

Though clinical and non-clinical problems are of inhouse, they need immediate attention if they occur. They can support you professionally addressing unexpected emergencies.

One can also cover in scope some services like documentation preparation, (510k submission, product labelling, US FDA Consultancy firms are not luxury but very essential especially if your products are sold in US and Europe territory. Though Europe legislations are slightly different, following US FDA and its approach will help resolving these problems too.