Tagged regulatory-affairs
Press Release
Pace® Life Sciences Acquires Meridian BioGroup, Expanding Regulatory, Compliance, and Validation Capabilities to the Biotechnology and Pharmaceutical Markets
Acquisition allows Pace® to provide regulatory and quality consulting services to support clients throughout the drug development process and improve commercial compliance in FDA-regulated environments. Read More
Press Release
Conducting Audit-Ready Literature Reviews for Your Clinical Evaluation Reports, New Webinar Hosted by Xtalks
This live webinar upcoming on February 28, 2018, is a must for anyone who is involved in the preparation of clinical evaluation reports (CERs) for medical devices. The presenters will cover practical, proven methods for conducting audit-ready literature reviews as part of the CER preparation process and will demonstrate these best practices using DistillerSR literature review software. Read More
Press Release
4C Pharma Attends the 6th Annual Pharmacovigilance & Risk Management Strategies Forum Munich
The 6th Annual Pharmacovigilance & Risk Management Strategies 2016 brings together Pharmacovigilance and Drug Safety Officers, EU and National Regulatory, Clinical Risk-Benefit Groups, Regulatory Affairs Officers, Consultancies, Local Medicines Authorities, CROs and others. Read More
Press Release
NetZealous Successfully Completes Seminar On, "The DHF, Technical File and Design Dossier"
This seminar examined the existing and proposed requirements for the FDA's Design History File (DHF) and its derivate documents, the Device Master Record (DMR) and Device History Record (DHR). Read More
Press Release
NetZealous Announces Completion of Seminar on Modern Approaches to Process Validation
This seminar offered in-depth learning on ways by which a firm can define a sustainable structure for its validation program; how Change Control and other quality programs impact the validation program, requirements that go into process design, design of facilities and the qualification of equipment and utilities, and on several other important related areas. Read More
Press Release
NetZealous Announces Completion of Seminar on GMP Compliance for Pharmaceutical
This course offered understanding of the regulatory requirements that apply to the testing and interpretation of test results as they relate to the monitoring and release of pharmaceutical products. Read More
Press Release
A Global Top 5 Dermatology firm (with EU HQ) selected MakroCare for RA Services
MakroCare has been awarded a project from an EU based one of the Global Top 5 Companies that is exclusively dedicated to Dermatology. Under this Agreement, MakroCare will be supporting them on several Dossier Management services including dossier preparation, customization and submission management. Read More
Press Release
Pennsylvania Bio Pharma Company selected MakroCare for CMC Regulatory Services
MakroCare has been awarded one more project from a Pennsylvania based Biopharmaceutical Company that focuses on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. Read More
Press Release
Webinar On - Key Factors To Write An Effective Standard Operating Procedure And Work Instruction
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Read More
Press Release
FDA Approval Of Generic Version Of Cancer Drug Doxorubicin Hydrochloride Liposome Injection Is Expected To Help Resolve Shortage Of Drug Supply
FDA approved generic version of cancer drug doxorubicin hydrochloride liposome which is used to treat patients with ovarian cancer and currently faced with shortage supply Read More
Press Release
SFL's Managing Director Invited to Speak at MEDTEC Europe Event in Stuttgart, Germany
SFL is pleased to announce that Shayesteh Furst-Ladani, SFL's Managing Director, has been invited to give a presentation on the classification and regulation of drug/device combinations at the MEDTEC Europe event to be held in Stuttgart, Germany. Read More
Press Release
Alnylam Pharmaceuticals, BioMarin Pharmaceutical Inc., And Cytonet Set To Speak On Conducting Effective Orphan Drug Research
Barbara Wuebbels, R.N., M.S., Oved Amitay, and Rod Monroy, Ph.D. set to speak at the Premier marcus evans Life Cycle of Orphan Drug Development & Commercialization Conference Read More
Press Release
SFL's Managing Director and Head of UK Office to Speak at DIA Combination Products Workshop in Basel, Switzerland
SFL to provide update on the latest revision of the European medical device and in-vitro diagnostics (IVD) legislation at one-day DIA Combination Products Workshop. Read More
Press Release
Synowledge Observes Rare Disease Day
Synowledge is a global provider of drug safety, regulatory affairs and related IT solutions to small, mid and large sized pharmaceutical and biotechnology companies. Our comprehensive outsourcing solutions combine the unique strengths of both onshore Read More
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