Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

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

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. 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

  1. The customized regulatory plan will provide
  2. Roles and Responsibilities
  3. Product Overview such as Intended Use, Indication for Use, Applications, Contraindications, and Users of Products
  4. Product Classification, Predicate or Equivalent Product Comparison
  5. 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)
  6. Applicable Domestic and International Regulations
  7. Safety and EMC Certifications
    a.    CE Mark
    b.    CSA
    c.    Notified Body
    d.    UL
  8. Quality System Certifications like ISO, QSR, and Site Registration etc.
  9. Regulatory Risks, Clinical Plans, and Requirements for Labeling
  10. 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

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