Orrery was approached by an industry confederation of companies manufacturing pharmaceuticals and adjacent products. Given their size and the specialisation of their staff, the client’s members often lacked consistent regulatory monitoring and compliance advisory capabilities in-house.

An Orrery consultant was attached to the interest group, to create a third party compliance centre of excellence for the area of pharmaceutical manufacturing, focusing mainly on the regulations that influenced the way pharmacauticals are produced and requirements that governments of the EU imposed on their production plants.

Orrery provides a long-term, ongoing engagement to members of this industry confederation, providing quarterly reviews of manufacturing painpoints, drafting joint responses to newly introduced regulatory legislature, monitoring of new regulations and ad-hoc consulting.

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.

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.

An Orrery consultant conducted a comprehensive assessment for one of the leading private banks in Central Europe in anticipation of the regulatory necessity to report data in accordance with principles of Basel III. In addition to that, the bank faced challenges driven by year of technical debt and paper-based processes, with inconsistent data across core banking systems, regulatory reports, and management dashboards, which undermined leadership confidence in key financial and risk metrics.

Through detailed data profiling, quality rule implementation, and gap analysis against regulatory requirements, Orrery identified critical issues in data accuracy, completeness, and timeliness, and delivered a prioritized remediation roadmap and governance recommendations.

As a result, the bank significantly improved the reliability of its regulatory and management reporting, reduced manual reconciliation efforts, and strengthened executive trust in the data used for strategic decision-making and risk management.

Orrery consultants led the design and implementation of a Target Operating Model (TOM) for several functional areas focusing on misalignment between holding process guidelines and subject business units’ day-to-day practice. These new holding guidelines were instigated by the recent adoption of new Insurance regulations across the EU, which required processes for service procurement, procurement vetting to be owned, documented and reported.

Working directly with the COO, the team analysed existing state of downstream adoption of process guidelines and rationality of roles and responsibilities and then designed new business processes and team units to bring regional and local operations in line with headquarters’ strategic objectives.

These proposed changes were supported by a new Operations TOM, which also covered non-regulatory changes to Operations teams and personnel changes to ensure a more efficient, cohesive, and strategically aligned cooperation between individual teams on both local and holding levels.

Orrery helped a Swiss mid-sized Pharmaceutical manufacturer with under-licence production lines within EU territory to deal with Regulatory communication and regaining compliance.

The client invited the scrutiny of one of the EU’s national healthcare regulators after an inspection at a production plant for OTC pharmaceutical products and was given a tight deadline for correction.

Orrery was brought in to review the entire library of the client’s manufacturing processes that were the subject of the client’s regulatory non-compliance. Its consultants designed compliant processes and communicated with the Regulator on behalf of the client, managing to prove correction of non-compliant practices within the stated regulatory deadline.

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.

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.

An Orrery consultant delivered the modernization and ongoing evolution of CEE region-level Loyalty Club reporting data based on country specific business and regulatory requirements. Orrery led continuous adaptation of reports to maintain compliance with rapidly changing heated tobacco legislation while upgrading technical foundations.

Orrery successfully brought 70% of the Loyalty Club reporting to modern standards using fully compliant processes and high-quality data. This significantly improved the reliability and timeliness of key business metrics used by leadership for performance tracking and strategic decisions.

The project reduced risk from regulatory non-compliance and gave executives greater confidence in the accuracy of the data underpinning their regional business strategies and customer program effectiveness.