Products Regulatory Affairs Quality Assurance Consulting Services and Products

Regulatory Plan, Strategy, Development and Execution for Medicinal Products, Drugs, Medical Devices and Combinational Products

1. Service Description

We create customized regulatory plan which provides an overview of the regulatory strategy and the regulatory requirements required to legally market the Medicinal Products, Drugs, Medical Devices and Combinational Products in various countries.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

We offer services for following marketing applications

Abbreviation	Description
510 (k)	Premarket Notification
ANADA	Abbreviated New Animal Drug Application
ANDA	Abbreviated New Drug Application
BLA	Biologic License Application
CA	EMEA Competent Authority
CTA	Clinical Trial Approval
IDE	Investigational Device Exemption
INAD	Investigational New Animal Drug
IND	Investigational New Drug
NADA	New Animal Drug Application
NDA	New Drug Application
PDP	Product Development Protocol
PMA	Premarket Approval Application
SNDA	Supplemental New Drug Application

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

Process efficiency gains (people)
Less personnel requirements (people)
Infrastructure efficiency gains (systems)
Infrastructure validation and maintenance (systems)
Delivering quality products
Avoid regulatory noncompliance cost
Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size	Small	Medium	Large
$Savings	> 80 %	> 80 %	> 80 %
Annual Sales	< $100 million	$100 million < Sales < $500 million	> $500 million
Number of Submissions	<= 2 per year	2 < Sub <= 4 per year	> 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach

The customized regulatory plan will provide
Roles and Responsibilities
Product Overview such as Intended Use, Indication for Use, Applications, Contraindications, and Users of Products
Product Classification, Predicate or Equivalent Product Comparison
Competitive Profile, Marketing and Regulatory Process Flow
Regulatory Strategy of Submissions and Registrations for
a.    USA
b.    European Union
c.    Latin America
d.    Canada
e.    Other (Rest of World)
Applicable Domestic and International Regulations
Safety and EMC Certifications
a.    CE Mark
b.    CSA
c.    Notified Body
d.    UL
Quality System Certifications like ISO, QSR, and Site Registration etc.
Regulatory Risks, Clinical Plans, and Requirements for Labeling
Manufacturing and Quality Assurance

4. Definitions

Intended Use: The objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.

Indication for Use: General description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

Labeling: The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or its containers or wrappers, or (2) accompanying such article.

5. Applicable Laws, Regulations and Standards

Guidance for Industry and FDA - Regulation of Medical Devices http://www.fda.gov/cdrh/manual/ireas.html
Regulatory Considerations in Drug and Device Development: The Process and the Science - http://grants.nih.gov/grants/funding/SBIRConf2005/PowersJ.ppt
The New Drug Development Process - Steps from Test Tube to New Drug Application Review http://www.fda.gov/cder/handbook/develop.htm