FDA, EMA, Health Canada, Israel (AMAR) and others.
We strive to develop your idea into an approved product.
We strive to develop your idea into an approved product.
Regulatory solutions for startup companies - easy, affordable, efficient.
No matter how large or small your company, no matter what market it is targeting - US (FDA), EU (EMA), CA (Canada Health), Israel (Isreal MoH) - BIOREG has all the experience you need.
What Our Clients Say
The team of BIOREG is proud of its many happy and loyal clients.
I have been working with Daniel for several months and can already highly recommend him as an excellent source of regulatory expertise. He is highly professional, carries out work in an extremely timely manner without this affecting the quality of his work. I plan to continue to use Daniel's expertise and services throughout our entire development process.
Executive Director of Innovative Ventures, BioLineRx
I had the privilege of working with Daniel on several projects. Daniel is a very smart, talented regulatory professional, who has a skill that all great consultants must have – the ability to present a clear regulatory landscape and determine regulatory solutions and challenges that are most critical to the product’ success. He also knows how to simplify complex regulatory language and educate all team players to execute on the fine details of the regulatory plan. I appreciate Daniel’s open style and his ability to clearly communicate. I enjoyed working with Daniel and would be very happy to have him on board in the future projects.
Dr Shlomo Via
I was lucky to have Daniel on board for several regulatory projects including bone products, OTC and prescription dental devices and food supplements. Daniel’s proactive approach and innovative solutions were extremely valuable and helped us to determine the most beneficial regulatory strategy.
CFO & Acting CEO, Wize Pharma
I have worked with Daniel on a number of projects over the last few years. He is highly professional with a deep knowledge of regulatory affairs. We have requested an analysis of several issues with varying complexity, but regardless his work is always of very high quality and prepared according to agreed timelines. I highly recommend Daniel as a source of regulatory expertise and look forward to working with him again in the future.
Director of IP, Biolinerey Ltd
I have known Daniel as co-worker for about four years. Daniel is very skilled in the field of drug regulation and most familiar with FDA and EMEA rules and guidelines. Furthermore, Daniel has developed knowledge and proficiency in searching, analyzing and selecting relevant information needed to support regulatory requirements. Aside from his profound professional skills, Daniel is an intelligent, open-minded, honest, dependable and very pleasant to work with.
Founder, Adaptive Airway Labs
Daniel’s regulatory expertise in the general wellness product area and attention to details were tremendously valuable for us. He is able to quickly understand the project objectives and priorities and provide important clarifications and contributions for the product claim possibilities.
General Manager, Rekah Pharmaceutical Industry Ltd/RITE/
Daniel prepared for us a medical device dossier. He has run all accompanying registration tasks independently until full completion thereby obtaining product registration certificate (CE marking) as requested for the marketing of medical device product in EU. Daniel handled this and other diverse and complex tasks in knowledgeable and efficient manner, always responsive to provide timely support.
Jack V. Talley
CEO, Izun Pharmaceuticals Corp.
I have known Daniel Albahari professionally for approximately two years. We have worked together on numerous projects involving regulatory activities in the United States, Canada and the European Union. I have found him to be a tireless, thoroughly dedicated colleague with deep expertise in the applicable regulations. We recently were able to obtain a 510(k) approval for a wound care hydrogel in the United States. Without Daniel’s efforts the product had no chance for approval. We also recently needed to obtain guidance for the type of device filing in the European Union for a mid-size pharmaceutical/dental company. Daniel was able to research the literature and provide a compelling argument in favor of our recommendation. He was also instrumental in obtaining IND clearance with CDER at FDA for a new oral mucositis rinse. These are just a few examples of the depth of his regulatory expertise and commitment to the job. I strongly recommend and truly enjoy working with such a professional.
I was very fortunate to have Daniel Albahari on board on several projects throughout the preparation of pre-IND package, and IND submission, including clinical study report and protocol processes. Daniel’s regulatory and quality expertise in this area, together with his attention to detail, was of tremendous value to us. Daniel was able to provide a very knowledgeable and efficient approach to the work while keeping within the scheduled timeframes. I’m very recommending Daniel as an expert in these regulatory activities.
M.Sc., QA Manager, Izun Pharma
I had opportunity to work with Daniel on various quality projects in the company. Daniel is an out of the box thinker with a very strong quality background in the world of drug and medical device development.
I was very fortunate to have Daniel working on my project. Daniel is a knowledgeable, pro-active, analytical and diligent regulatory affairs professional. A result driven team player with strong work ethics and proven abilities in meeting challenges efficiently.
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