US FDA Registrations - GCP Consulting / Training:

Brief Company Information

FDASmart Inc., located in Amawalk, New York with offices in India and China (RO) is a pharmaceutical services company with “deep” roots when to comes to dealing with US FDA matters.

We helped Pfizer (Central Research, Groton, CT) establish a 100% Pfizer owned clinical data management CRO operations in India which we managed in the 1990s. We’ve assisted various Pharma companies with NDAs, ANDAs and INDs filings and conducted US FDA GMP audits in the US, Korea, India and China.

FDASmart constantly monitors the latest US FDA regulatory mandates and policies in the pharmaceutical, biotech, biologics and medical devices industry and has a unique (former) US FDA Insider advantage with its 2 most senior consultants. (see below for GCP Former US FDA staff/Training)

FDASmart can assist your company with the following services:
US FDA Registrations & Compliance:

The U.S. FDA regulates compliance for drugs products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Services we offer related to US FDA matters include:

US FDA NDA, ANDA(generics), IND and medical device filing (510K)

US FDA New Drug Establishments Registrations & Listings & US FDA Agent Representations

Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA.

These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign establishments must identify a U.S. agent at the time of their registration, i.e. electronic Drug Registration and Listing System (eDRLS)

Registration information must be renewed annually. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual establishment registrations in the period from October 1st to December 31st of each calendar year. In addition, be advised that at the time of annual registration, firms must list any drugs not previously listed.

Paper to Electronic Conversion for the New U.S. FDA Electronic Drug Registration & Listing System

As of June 2009, all establishment registrations, drug listings, annual renewals, and updates must be submitted to U.S. FDA electronically. Establishments that were previously registered with the U.S. FDA may be able to transition their old paper filings to U.S. FDA's new Electronic Drug Registration and Listing System (eDRLS).

Drug Master File (DMF)
Drug Master File is filed with the U.S. FDA to support pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. We provide assistance as to the required module elements, formats and content of Drug Master File submissions.
US FDA GCP (Good Clinical Practice) Training & Webinars/Audio conferences

Our unique value proposition is knowing how US FDA reviewers think and work ie our main Good Clinical Practice (GCP) expert and FDASmart President, Dr Joshua Sharlin was a former US FDA drug reviewer, has trained well over 45,000 with proprietary audio conferences and on-site training. Other GMP expert partners are world class US FDA compliant veteran professionals and most have done work in India.

Dr. Josh Sharlin
“As a Former US FDA reviewer, I bring to FDASmart expert compliance and submission know-how”.

Training 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.
  To see list of Audio-conference Topics, please click below URL  
  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.