Our ServicesDue Diligence

Whichever sector you operate in, investment and acquisition decisions require careful due diligence to mitigate the risks and define the size of the opportunity. The tightly regulated healthcare sector presents specific due diligence challenges which require specialist input.

How can AdverCheck help with due diligence?

The success of a healthcare company hinges on the safety, efficacy, and regulatory viability of its products. If you’re considering investing in or acquiring a healthcare product, brand or company, we can provide the insights needed to navigate your way with confidence – minimising risk and maximising potential.

We work with investors and companies considering acquisitions across a wide range of healthcare products including:

over-the-counter medicines
self-care medical devices
software as medical device (SAMD)
food supplements
health-related cosmetics
health and wellness products and services
consumer diagnostics.

Is the product effective & what claims can it make?

Even the most innovative ideas can fail without a solid foundation. Clinical efficacy is a critical factor in determining whether a product reaches the market, and robust efficacy data forms the basis of core promotional claims. Where relevant, efficacy data is also critical to securing reimbursement.

Our team has specialist expertise in clinical study design and interpretation. We can assess available clinical data to determine efficacy and identify strengths and weaknesses compared with competitor products. We can also advise on which claims would be supportable based on the clinical data and the relevant advertising codes. For early-stage products, where clinical trials may not have been completed, we can evaluate the underlying science and mechanism of action to determine “proof of concept”.

Is the product safe?

All healthcare products carry risks as well as benefits, and understanding potential safety issues should always be the first step in healthcare due diligence. Safety and tolerability issues can significantly impact the end-user experience and may lead to regulatory hurdles or even product withdrawal. AdverCheck can identify and quantify relevant risks based on a full evaluation of the available data and can propose measures to mitigate risk.

What is the legal classification & which regulations apply?

Knowing which regulations apply is critical to planning a product’s route to market and assessing its chances of success. This is particularly important for “borderline” products which sit between two or more product classifications. AdverCheck can advise on the most appropriate legal classification for your products, define the regulatory requirements and flag potential barriers that may be encountered.