Kivo’s expanded platform brings compliant collaboration and intelligent process automation to emerging Regulatory, Clinical and Quality teams.

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.

Achieving 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.

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.

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.

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).

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.

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.

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.

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.

A must attend webinar for those personnel that require an understanding of the FDA's requirements for PMA annual reports.

Investigator-Led Research, Timeline and Resource Management Among Session Topics at Inaugural Event

Compliance Trainings focuses on providing regulatory and quality web based online trainings to industry professionals across the globe.

Compliance Trainings focuses on providing regulatory and quality web based online trainings to industry professionals across the globe.

Compliance Trainings addresses a variety of pivot points that includes the communication of most recent updates in regulatory compliance arena and best practices.

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.

MakroCare announced the addition of Vistaar, a Regulatory Intelligence tool, to it's Regulatory Affairs portfolio.

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

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.

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

Interview with Tatyana Chorny, Regulatory Affairs, Post-Market Surveillance & Complaints Management at Philips Healthcare

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.

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

Dr. Laurie Smaldone joins Princeton-based strategic regulatory communications firm, PharmApprove, as President

Educational 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