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 Press ReleaseAchieving Orphan Drug Designation is a significant step enabling your product to be licensed faster, in a cost-efficient manner, and achieve market exclusivity for 10 years.
Read Press ReleaseThis 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 Press ReleaseThe 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 Press ReleaseThis 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 Press ReleaseThis 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 Press ReleaseThis 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 Press ReleaseMakroCare 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 Press ReleaseMakroCare 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 Press ReleaseThis 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 Press ReleaseFDA 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 Press ReleaseSFL 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 Press ReleaseBarbara 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 Press ReleaseSFL 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 Press ReleaseSynowledge 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 Press ReleaseEducational Services Division of UK based MNC,Helix Research Center Ltd has announced 'Advanced Web Based,Live Training Program for GCP and GXP Trainers' conducting Training for Clinical Research and Healthcare Industries etc Worldwide
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