An Orrery consultant led the project helping an Asian manufacturer of COVID-19 IVD testing kits to gain sale approval from EU regulators amidst the COVID-19 pandemic in Europe, so they could supply laboratories within EU territory.

Orrery made use of the unique exemptions declared by the EMA on the In Vitro Diagnostics segment and the harmonisation mechanic to gain sale authorisation for the EU market under the Medical Device Directive for the client within a few weeks.

Orrery then provided a follow-up service, acting as the client’s designated responsible person for the purposes of regulatory communication regarding the client’s authorised products.

Orrery delivered market entry advisory, partner search and due diligence for a client in the Defence industry which manufactures primarily drones, ammunition and electronics for military vehicles. The client experienced a sales surge on the European market and identified successfully establishing manufacturing capacity in India that qualified the client to participate in Federal Ministry of Defence tenders. However, such participation requires the foreign defence contractor’s adherence to a set of regulations known as Make In India, which are designed to protect indigenous Indian businesses and increase their market share on the global defence and aerospace market.

An Orrery consultant aided the client’s international growth director in analysis of the Make In India III regulation, which outlines the commodities that a foreign company cannot sell to or in India without Indian businesses participating in the manufacturing process. Past experience with attempted Indian Joint Ventures, however, fostered a fear of reverse-engineering of patent-protected technologies and attempts at industrial espionage by their chosen lincence partners.

Orrery helped the client create an impenetrable legal framework with the aid of a partner Indian legal team with the ability to enforce penalties part of any deal made on Indian soil. Later, helping the client with understanding of inner workings of Indian federal tenders that would later dictate the selection of the proper Joint Venture partner.

Orrery was brought in by the local EU representative of a South Korean manufacturer of pharmaceuticals, medical devices and cosmetic products. The client’s problem was, that the EU was about to switch from one regulatory standard to another, and while the client formally adhered to the earlier standard, they weren’t compliant according to the new one.

The older standard, called the Medical Device Directive (MDD), categorised different medical devices, assigning each category a set of compliance, usage oversight and reporting requirements, with some categories being allowed to self-declare compliance and self-report under specific circumstances. The Medical Device Regulation (MDR), which replaced the MDD as the lawful regulatory principle, was much more strict in terms of compliance declaration and oversight, requiring Notified Bodies, a network of attested regulatory and research firms, to become a decision maker on compliance of products.

However, since the market participants struggled to adjust to the new, stricter set of rules in time for the implementation deadline, the EU extended a grace period for those manufacturers who had been compliant under the MDD for multiple years under specific requirements. Orrery guided the client through these requirements, analysed their product and manufacturing documentation to make it ready for the switch to MDR and found a Notified Body partner willing to sponsor an exemption for the client by the EU by becoming an exclusive product data oversight partner.

A team of Orrery consultants performed an on-site project for a mid-sized pharmaceutical manufacturer from northern India. The client’s goal was to penetrate the EU market and gain regulatory approval for its products.

Due to the client’s extensive range of products, Orrery first created a shortlist of products to introduce foremost based on current consumer trends on the EU market and regulatory complexity of each product line. The client’s process for extracting the efficient compounds of their products was such that EU legislation allowed it to be registered as a food supplement, rather than medicine. This allowed the client to save on regulatory costs and on years of time otherwise spent on the regulatory process.

Orrery led the authorisation process with the appropriate regulators – national authorities for products with established ingredients and the European Commission for products that contained Novel Foods – and subsequently helped the client find physical shelf space and distribution from one of the Top 5 supplement distributors in the CEE region.

An Orrery consultant was attached to the Commercial Director of a company manufacturing retail goods aimed at school-going children, such as classroom stationaries, school bags, etc. The client approached Orrery with the goal of penetrating the North American market, starting with the USA.

The client already was in negotiations with a distributor that was willing to take on the client’s products, however, the deal stalled because the client was repeatedly unable to get authorisation for the sale of their products from the United States Consumer Product Safety Commission.

Orrery consultants helped the client by creating proper, regulatory compliant documentation for the products in question and communicated with the CPSC on behalf of the client to secure authorisation for their products, allowing the stalling deal with the distributor to go forward.

A team of Orrery consultants advised the board of a local business unit of a major Asian logistics company whose main business revolved around building supply chains between South East Asia and Europe and facilitating B2B transactions on where the supply chain reached.

The client’s executives faced a challenge of discerning the market potential of products they had under control. The Orrery team produced a two-part solution, one part centered around sizing the market for client’s transported goods and analysing their potential, and another part focused on improving the client’s B2B sales and pre-sales processes.

The client’s sales process was optimised for sales work in South East Asia and their account managers struggled to deliver in European markets. The B2B sales process was overhauled and successfully piloted within a 1-month deadline set by the client.