Services :

 

FDASmart offers a number of products and services all designed train and guide pharmaceutical companies in the complex and arduous path to drug discovery and clinical research studies as it RELATES TO US FDA regulatory compliance.

We do this a number of ways:

(a) Live Audio Conferences/Training delivered from the US This is a proven and time tested economical way to train pharmaceutical and CRO companies. These live audio conferences are conducted by Dr. Joshua Sharlin personally for 90 minutes. 30 minutes thereafter is allotted for Q&A. Dr. Sharlin has authored around 30 topics and has trained well over 30000 students in US and Europe over the last few years. A list of the live audio conferences and a brief description are included below.

Fees for participating with the live audio conference vary by topics but will begin from Rs 20000 per connect location with multiple listeners per location permitted. Calls are local from India.

Hand-outs are emailed ahead of the conference time and may be distributed freely.

Where else can one in India "buy" world-class, best-of-breed consulting by a former US FDA drug reviewer at such low pricing?

To see list of Audioconference Topics? Please click below URL

www.fdasmart.com/listoftopics

 

(b) Sponsored Live One-day Symposiums -India

(c) Coming Soon!

 

Local manufacturing GMP compliant audits and US FDA mock inspections in China or India REMOTELY MONITORED AND SUPERVISED by one of our by ex-FDA US GMP & CMC expert inspectors using the our exclusive SmartInspect technology system.

PAT compliant (Process Analytical Technology) walk throughs sanctioned by the US FDA can be delivered without the costly investment of an actual on-site expert consultant at your premises.

Let FDASmart assist you with:

Remotely supervised GMP compliance audits of:

. Manufacturing Facilities
. Analytical Laboratories
. Clinical trial material manufacturing facilities
. Contract manufacturing facilities (CRAMS)
. Distribution Centers

Using our state of the art SmartInspect system and a wearable, wireless video surveillance gear, your company representative can be remotely guided by US based FDASmart at your location.Real time video and audio is transmitted as the mock inspection happens.The entire session can be recorded and archived to serve as audit documentation or re-purposed for training others within your company,etc.

Its like having a US FDA expert stand next to you AT YOUR SIDE during your analytical laboratory, supplier API manufacturing plants or warehouses MOCK inspections Proven real-time two way audio communications allows an FDASmart expert to see & conduct the mock FDA inspections as though he was there you Schedule ahead over the web on our site, mock inspections will be conducted at local time convenient to your staff. No need for costly and overpriced consultant/inspectors travel & accomodations expenses. SmartInspect service can be priced per use or on a recurring plan to lower costs even more.

The US FDA is coming will you be ready

China and the United States, seeking to ease the furor over the safety of food exports, signed an agreement Tuesday calling for a greater American role in certifying and inspecting Chinese food products, including an increased presence of American officials at Chinese production plants.

Michael O. Leavitt, secretary of health and human services, said he expected that Food and Drug Administration officials would eventually be embedded in Chinas food safety bureaucracy to help train Chinese officials and keep records on their inspections.

The Chinese recognize, as do we, that having F.D.A. personnel here would expedite the process of capacity building and increase cooperation and communication, Mr. Leavitt said. I am optimistic that it will occur.

 See how SmartInspect works? Click here