Acquiring a new trademark, new factory or new business is a calculated risk. Regulatory due diligence and an acquisition audit are essential to identifying the regulatory compliance and potential of your target.
Whether it’s a planned merger, acquisition, sale, or licensing arrangement, the RNI team coordinates and performs regulatory, medical or quality due diligence in the field of nutritional products, food supplements, medical devices, cosmetics and OTC products.
The compliance of a product portfolio, a factory or a trademark is one of the factors that go into the valuation of an asset. The regulatory audit identifies departures from regulations. RNI Consulting corrects those departures with tailored solutions. Through its experience with a variety of investors, investment banks and large pharmaceutical, cosmetics and food companies, RNI Consulting has developed solid experience in the due diligence and M&A process, for various companies and brands.
1. The regulatory audit pre-report
(making use of the dataroom, interviewing regulatory staff, managing the regulatory Q&A)
2. The final due diligence report, which includes, depending on what you request:
An audit of compliance with current national, EU, US and international regulations, plus an assessment of the regulatory impacts 3 and 5 years out.
- (1) compound,
- (2) claims/indications
- (3) marketing approach, including date of introduction
An audit of scientific and regulatory expenditures to ensure that the products can be kept on the market (in the event of new regulatory requirements, new countries in the sales plan, or obsolete or outdated marketing authorizations)
A quality audit of factories against international standards (ISO 22000, HACCP and ISO 13485 for medical devices and ISO 22716 for cosmetic products)
An assessment of the departures and of the regulatory, medical and human resources necessary to bring the brand or the company into compliance
An assessment of the company or brand in light of the country’s healthcare policy