We are a regulatory affairs consulting firm dedicated to providing full regulatory support to medical device and biotechnology companies.
The focus of our practice is to advise on regulatory matters relating to the US (FDA), European Union (EMA), Canada (Health Canada) and Israel (Israel MoH).
For start-up companies and innovative projects, we advise on regulatory strategy and planning for the client’s products.
Extensive professional knowledge and experience, along with scientific insight, enables BIOREG to develop optimal regulatory strategies thereby achieving shorter approval times and greater marketing potential for our clients and their products.
For companies in the pre-approval phase, we advise on product development, preclinical and clinical trial issues, communications with the FDA and Notified Bodies during the review process and regulatory affairs strategy including premarket notifications (510k), premarket approval applications (PMA), combination products, homeopathic drugs, 505(b)(2) new drug applications and orphan drugs.
For those companies in post-approval phase, BIOREG advises on regulatory maintenance, post-market surveillance programs and clinical evaluation reports.
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