The Drug & Device Development Co., Inc Company Profile

09:07 EDT 22nd June 2018 | BioPortfolio

The Drug & Device Development Co., Inc. founded in 1985, has expertise in the regulatory, clinical, quality and statistical aspects of drug, biologic, diagnostic, and medical device development. The DDD group consists of both full-time and part-time specialists. Each one is well experienced in one or more aspects of the drug, biologic and/or device approval process.The major focus of DDD's services is related to product approval support. Services include the following: regulatory and clinical strategies and implementation for pre-market submissions, pre-clinical and clinical study design, protocols, monitoring, clinical auditing, data entry, database management, statistical analysis and evaluation, report writing and training. DDD assists companies in setting up Design Controls, ISO and GMP compliance programs.


P.O. Box 3515
United States of America


Phone: (425) 861-8262
Fax: 425) 869-5854

News Articles [2539 Associated News Articles listed on BioPortfolio]

FDA Permits Marketing of New Device for Treating GI Bleeding

TUESDAY, May 8, 2018 -- The U.S. Food and Drug Administration has approved the new Hemospray device to help control bleeding of the gastrointestinal (GI) tract. The new device "provides an additional,...

TSB - SBRI Competition - Applications Requested

Drug driving is an increasing problem on UK roads.  Use of an oral fluid drug screening device would significantly assist the detection of drug drivers by the police. The Home Office Scientific D...

FDA approves Photocure's new drug and device combination to detect bladder cancer

Norway-based Photocure has secured approval from the US Food and Drug Administration (FDA) for new drug and device combination to detect bladder cancer.

Surmodics to license SurVeil drug-coated balloon device to Abbott

Surmodics, a provider of surface modification, drug delivery, and in vitro diagnostic technologies to the healthcare industry, has agreed to exclusively license its SurVeil drug-coated balloon device ...

FDA Restricts Sale and Distribution of Essure

NewsThe U.S. Food and Drug Administration today issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception devic...

Device-drug interface product classification guidance updated by Canada

The 2013 guidance on classifying products at the device-drug interface was updated by Health Canada to reflect modifications  -More- 

FDA plans to advance medical device cybersecurity

The US Food and Drug Administration (FDA) has unveiled new efforts to improve and modernize its approach to medical device safety and innovation.

FDA issues recall on J&J heart device

REUTERS: The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve. The valve, which prevents blood from flowing ...

PubMed Articles [4703 Associated PubMed Articles listed on BioPortfolio]

Design and Fabrication of a Magnetically Actuated Non-Invasive Reusable Drug Delivery Device.

We present a novel approach of designing and fabricating a non-invasive drug delivery device which is capable of delivering the drug to the target site in a controlled manner. The device utilizes a re...

Transparency and Dermatologic Device Approval by the US Food and Drug Administration.

The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental de...

Development of a Device-Assisted Nerve-Regeneration Procedure in Disruptive Lesions of the Brachial Plexus.

 We describe the development of a new surgical procedure to be used in the treatment of disruptive brachial plexus (BP) lesions. It is centered on an artificial device designed to assist nerve regen...

Product Approvability Recommendations From FDA Advisory Committees:: Inconsistently Sought, Indirectly Obtained.

Divisions within the Food and Drug Administration (FDA) often convene meetings of advisory committees, also known as AdComm or Panel meetings. The purpose of many AdComm meetings is for the FDA to obt...


This paper describes the DIOGENES database available though BRS Information Technologies. The database focuses on drug and medical device regulatory information from the Food and Drug Administration. ...

Clinical Trials [7101 Associated Clinical Trials listed on BioPortfolio]

Medical Device for Drug Allergy Diagnosis

The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most preva...

Calibration of a New Reflectance Oximeter.

This study is about the development of a new medical device for the monitoring of of sleep disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of an ox...

FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis

Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high bur...

Development of a Screening Strategy for Community-Based Adverse Drug Related Events in the Emergency Department

Adverse Drug Related Events (ADREs) are a leading cause of Emergency Department (ED) visits in Canada. However emergency physicians recognize only half of all ADREs in patients presenting ...

An Arts Intervention for Drug-Using Homeless Youth

In the study, homeless youth from a drop-in site and faculty from UCLA and California Institute of the Arts will develop, pilot test and evaluate a youth-based drug and health-promoting pr...

Companies [3829 Associated Companies listed on BioPortfolio]

The Drug & Device Development Co., Inc

The Drug & Device Development Co., Inc. founded in 1985, has expertise in the regulatory, clinical, quality and statistical aspects of drug, biologic, diagnostic, and medical device development. The D...

Abingdon Life Sciences, Inc.

Abingdon Life Sciences, Inc. is a first-in-class Drug and Device Development Management Organization (DDMO) providing drug and device companies superior clinical and regulatory services based on a...

AvAMed Consulting Group, Inc

Experienced Consultants to the Pharmaceutical, Biotechnology,Central Laboratory, e-Business, Diagnostics, CRO and Medical Device IndustriesAvAMed Consulting Group is comprised of dedicated professiona...

PCG Medical Alliance

PCG Medical Alliance is a privately held alliance of small but experienced, efficient and specialized Contract Research Organizations, which provides the complete range of Drug or Device Development a...

Jubilant Clinsys Inc.

Jubilant Clinsys Inc. is a scientifically focused contract research organization that provides pharmaceutical, biotechnology and medical device companies with a full range of serv...

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We have published hundreds of The Drug & Device Development Co., Inc news stories on BioPortfolio along with dozens of The Drug & Device Development Co., Inc Clinical Trials and PubMed Articles about The Drug & Device Development Co., Inc for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of The Drug & Device Development Co., Inc Companies in our database. You can also find out about relevant The Drug & Device Development Co., Inc Drugs and Medications on this site too.

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Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Medical Devices
The role of medical devices in healthcare is essential.  The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare.  Covering a wide range of products, from simple bandages to the...

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