Regulatory Strategy Planning
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
BIOREG helps clients to identify, define and broaden the regulatory potential of their technologies. This is achieved by analyzing all viable regulatory options which are applicable to the client’s product whilst recognizing the practicalities and needs of the client’s business.
BIOREG’s strategic advantage is in its ability to identify easy and often innovative solutions within the regulatory milieu. The firm examines all the potential regulatory avenues available to a client to determine and develop the most beneficial strategies for products in each individual case.
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.
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because combination products involve components that would normally be regulated under different types of regulatory authorities, they raise challenging regulatory, policy, and review management challenges.
Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
We’re here to provide the best regulatory strategies during the approval process of your product.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.