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.

Your Medical Device & Combination Product Regulatory Consultants

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.

BIOREG can provide a cost-effective, clear and detailed regulatory strategy and regulatory plan which will serve as a powerful development and business tool.

FDA Medical Device Regulation – Combination 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, and frequently by different FDA Centers, 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 FDA approval process of your product.

CONTACT US

In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

REGULATORY PACKAGES FOR STARTUP COMPANIES

We have created several packages for startup companies that will help you in every step of regulation process for your medical device or other medical product.

EU Borderline Products: Medical Devices or Medicinal Products

The demarcation between the Medical Devices Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) on the one hand and the Medicinal Products Directive (MPD) on the other hand is crucial for the proper implementation of these Directives and the correct interpretation and enforcement of national laws in EU.

Borderline cases are considered to be those cases where it is not clear from the outset whether a given product falls under the MDD, AIMDD or the MPD. It is therefore necessary to examine both prerequisites. We are here to help you with classifying your borderline product in the most beneficial way in EU. Get in touch with us to inquire about the Regulatory strategy we can provide!