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 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.

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.

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.

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.