The Drug & Device Development Co., Inc Company Profile

03:16 EDT 23rd March 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 [2623 Associated News Articles listed on BioPortfolio]

FDA's generics goals may spell trouble for branded drug-device combos

With an eye to drug pricing, agency head Scott Gottlieb said the FDA is taking "taking new steps" to finalize guidance for generic drug-device combos.

Medical Device Development Tools: Helping to Speed Medical Device Evaluation and Approval

By: Hilda F. Scharen, M. Sc., Capt. USPHS, and Jeffrey Shuren, M.D., J.D. FDA relies on sound science in its decision-making, which provides medical device innovators with a strong base for their prod...

New multipurpose device to help prevent HIV and pregnancy

(RTI International) To help empower women in low- and middle-income countries and improve their health, the U.S. Agency for International Development through the U.S. President's Emergency Plan for AI...

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 ...

Going Solo: Combo Products With Device But No Drug Sponsor To Get Hearing

US FDA seeking input on proposed approach to allow device sponsors to seek marketing authorization for a device labeled for...    

Takeda, Portal Instruments partner to develop needle-free drug delivery device

Japan drugmaker Takeda has collaborated with medical device firm Portal Instruments to develop and commercialize needle-free drug delivery device.

FDA: Puerto Rico's critical medical device industry struggling after hurricanes

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PubMed Articles [4625 Associated PubMed Articles listed on BioPortfolio]

Development of a Poly-ε-Lysine Contact Lens as a Drug Delivery Device for the Treatment of Fungal Keratitis.

The purpose of this study was to develop a more efficient drug delivery device to overcome the limitations of current drop therapy for the treatment of fungal keratitis.

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...

Drug development for breast, colorectal, and non-small cell lung cancers from 1979 to 2014.

Understanding the drug development pathway is critical for streamlining the development of effective cancer treatments. The objective of the current study was to delineate the drug development timelin...

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...

Drug-device combination approaches for delivery to the eye.

While the eye is readily accessible from the outside of the body, it is a rather isolated organ with a number of barriers and elimination mechanisms in place to protect it from the environment, render...

Clinical Trials [6770 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 [3794 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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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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