Search Results for: DEVICE REGULATIONS Early Preparation Will
Articles
DEVICE REGULATIONS - Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations January 8, 2018
Joanne Emmett says current directives are giving way to new regulations that require Class III and implantable devices to undergo clinical investigation to show that they are equal or superior to other products on the market.
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market September 6, 2019
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
ADVANCED DELIVERY DEVICES - How Data Hubs & Smart Devices Are Enabling the Rise of Therapeutic Ecosystems January 8, 2016
Stephen Allan discusses how unique collaborations between tech and biotech reflect a new paradigm in how therapeutics are being commercialized and marketed under the new pay-for-performance healthcare model.
EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis March 1, 2023
Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.
SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market May 3, 2021
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
SPECIAL FEATURE - Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis January 14, 2021
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
COMBINATION PRODUCTS - Development Challenges & Solutions August 31, 2020
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
MULTIPARTICULATE FORMULATIONS - Using Multiparticulate Technology to Develop Pediatric Drug Products February 28, 2019
Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.
SPECIAL FEATURE - Analytical Testing - Contractors Take on the Challenge of Complex Molecules January 9, 2018
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
SPECIAL FEATURE - Injectable Drug Delivery: New Technologies Deliver Biologics & Differentiate Brands September 12, 2017
Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future May 5, 2015
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development January 8, 2015
Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.
SPECIAL FEATURE - Analytical Instrumentation Gets Faster, Smaller, and Easier to Use March 12, 2013
Contributor Cindy H. Dubin learns that one doesn’t have to be a rocket scientist to use analytical instrumentation. Three leading players in the market showcase their products, all aimed at making analysis easier and faster.
WHITEPAPER - Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products
Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..
