Online Safety Community

Which can leave the work of meeting regulatory requirements to FDA Services

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these organizations.

Why do companies offer FDA consulting service?

FDA consulting services are offered because most organizations find the maze of FDA regulation too complex, confusing and time consuming. FDA consulting services are an easy way out for these organizations, which can leave the work of meeting regulatory requirements to FDA consulting services and concentrate on their core areas of business.

1https://compliance4all14.files.wordpress.com/2018/04/1.jpg?w=1114&h=464 1114w, https://compliance4all14.files.wordpress.com/2018/04/1.jpg?w=150&am... 150w, https://compliance4all14.files.wordpress.com/2018/04/1.jpg?w=300&am... 300w, https://compliance4all14.files.wordpress.com/2018/04/1.jpg?w=768&am... 768w, https://compliance4all14.files.wordpress.com/2018/04/1.jpg?w=1024&a... 1024w" sizes="(max-width: 557px) 100vw, 557px" width="557" height="232" />

What do FDA consulting services do?

FDA consulting services usually carry out all tasks associated with and required for meeting FDA regulatory requirements. While they may not be involved in the business per se, they help in the documentation part, because this is where their help is required. FDA consulting services help companies in achieving and maintaining all aspects of FDA compliance. This is done for a fee, of course, and is considered legal outsourcing.

In what areas are FDA consulting services offered?

Most FDA consulting services companies offer consulting relating to everything about FDA regulation, although some FDA consulting services companies do so only in select, specialized areas. The services offered by FDA consulting usually include the following:

  • Helping before,during and after an FDA inspection
  • FDA 510(k) Submissions
  • Audits and inspections
  • Audits and gap analysis
  • Writing Standard Operating Procedures (SOPS) forms and reports
  • Form 483 and responses
  • Responses to Warning Letters
  • Investigational Device Exemption (IDE) submissions
  • Serious Adverse Event Reporting
  • Medical Device Reporting

Many FDA consulting services companies offer advice on drugs, dietary supplements, clinical trials, food and tobacco, and medical devices. They also carry out complex tasks like QSR reviews, GCP, GMP, GLP audits, New Drug Application (NDA), Biologic License Application (BLA), Abbreviated New Drug Application (ANDA) and Premarket Approval (PMA), as well as remediation for companies that have to respond at short notice to compliance issues raised by the FDA.

Views: 32

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Kyle C. Johnson posted a discussion

[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their phones at any time, anywhere. Even the PIT drivers. It's insane. My initial reaction is to say NO HEADPHONES WHATSOEVER, but my ops manager is concerned it will drastically reduce morale. I suggested that each department should have their own radio and they can play music for everyone to hear, at a…See More
8 hours ago
John Robinson posted a blog post

Nutrition Facts labels of pure maple syrup and honey

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.This update to the Nutrition Facts label has incorporated the latest…See More
16 hours ago
Mark Nilson posted events
17 hours ago
HrishikeshRam posted blog posts
20 hours ago

Forum

[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson 8 hours ago.

AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

Tags: elite, crest, technologies, intelligence, Artificial

Started by emmablisa on Monday.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Safety update: OSHA announces fit-test procedures 1 Reply

Fabricators as well as other workers may be required to use respirators to protect themselves from inhaling fumes, particles, or dust when performing cutting, grinding, welding, coating, or painting,…Continue

Tags: online, training, Safety, workplace, PPE

Started by Safety Training International. Last reply by Jen McDade Dec 4.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service