New PressRelease information at Drug Development Technology New and updated information from PressRelease listed on en-us New PressRelease information at Drug Development Technology Biovian to Present at Bio-Europe in Germany Biovian has announced it will be present at the biotechnology partnering Conference Bio-Europe in Cologne, Germany. Wed, 19 Oct 2016 14:56:00 GMT Malvern to Demonstrate New Nanoparticle-Size and Concentration Measurer in Webinar Malvern has announced it will be demonstrating the NanoSight NS3000, which uses Nanoparticle Tracking Analysis (NTA) to measure nanoparticles and concentrates. Mon, 10 Oct 2016 14:32:00 GMT Drug Labeling Types Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling and includes reference to the regulatory basis for each. Wed, 28 Sep 2016 15:04:00 GMT Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application? Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy? Mon, 26 Sep 2016 15:04:00 GMT Biovian's CEO will be Available for Discussions at Three Events in Europe Biovian will be present at Nordic Life Science Days, BioTalk, and Bio-Europe. Thu, 08 Sep 2016 15:14:00 GMT Measuring Zeta Potential for Product Stability and Performance Cosmetics, paints, inks, paper, drug delivery, personal care, food or intra-lipid emulsions are made up of multi component chemistries. Most products go through a stage where different phases co-exist such as emulsions, suspensions or dispersions and… Thu, 08 Sep 2016 10:01:00 GMT Six Must-Read Scenarios for FDA Consulting FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for further drug and device development. Wed, 31 Aug 2016 16:21:00 GMT Morphologi G3-ID Used by FDA to Approve a New Nasal Spray Key data for the approval of a nasal spray containing mometasone furoate has been obtained by the Food and Drug Administration (FDA) through the use of Malvern's Morphologi G3-ID system. Thu, 18 Aug 2016 15:48:00 GMT BioOutsource's new Website is Live Featuring Cellca's Cell Line and Upstream Process Development Services International supplier for the biopharmaceutical industry Sartorius Stedim Biotech (SSB) has announced that its subsidiary BioOutsource has launched an updated website to showcase Sartorius Stedim Cellca's cell line and upstream process development s… Fri, 22 Jul 2016 10:24:00 GMT Third-Party Reviews for Developments Programmes Deciding whether third party review is a favorable cost/benefit proposition for a given 510(k) development programme is not always clear. Thu, 14 Jul 2016 16:21:00 GMT Sartorius Stedim Biotech Releases Expandable Benchtop Workstation ambr® 250 Sartorius Stedim Biotech (SSB) has introduced the ambr® 250 modular, which offers a simple approach to process development for fermentation and cell culture. Mon, 11 Jul 2016 10:14:00 GMT PBSC Presents the Ultrasonic Fog Shower Offering a better performance to regular misting showers, the ultrasonic fog shower can remove airborne particles and API from the operator's clothes. Wed, 06 Jul 2016 13:57:00 GMT PBSC Offers Blast-resistant and Pre-engineered Sliding Doors PBSC offers a range of pre-engineered sliding doors and single and double leaf hinged blast resistant doors. Wed, 06 Jul 2016 13:39:00 GMT Micromeritics Awards a Grant to University of Basque Country Micromeritics' Instrument Grant Committee has awarded an AutoChem II 2920 to the University of Basque Country. Wed, 29 Jun 2016 13:58:00 GMT Micromeritics Extends 3Flex Surface Characterisation Application with New TCD Option It has been announced that Micromeritics Instrument is adding a thermal conductivity detector (TCD) option to its 3Flex Surface Characterisation family. Wed, 29 Jun 2016 13:42:00 GMT Sartorius Stedim Biotech Launch Virus-Retentive Filter Virosart in Germany International supplier Sartorius Stedim Biotech (SSB) has released a new virus-retentive filter for use in cell culture media. Thu, 23 Jun 2016 15:20:00 GMT Drug Product Label Advice Drug product labelling is the primary communication tool for any drug product. Wed, 22 Jun 2016 16:37:00 GMT FDA Expedited Development & Review Programmes Explained FDA consultants take note: expedited development and review programmes have now been used by CDER for more than two decades. Thu, 16 Jun 2016 12:34:00 GMT The new Zetasizer AT – Automated Online Nanoparticle Sizing for Process Monitoring Malvern Instruments has launched the new Zetasizer AT, a robust, online, automated analyzer that uses dynamic light scattering (DLS) to automatically measure the size of nanoparticles in suspensions and emulsions. Tue, 07 Jun 2016 14:38:00 GMT Guidance for FDA's Pre-Submission Programme Pharmaceutical consulting and generic drug professionals: On February 18, 2014, the final guidance document was released regarding FDA's Pre-Submission programme, Requests for Feedback on Medical Device Submissions: The Pre-Submission Programme and M… Thu, 02 Jun 2016 16:00:00 GMT