Business Case: China Entry Strategy

A leading medical devices company had decided to enter the Chinese market with one of their product lines. Two consultants in Shanghai and Beijing assessed the regulatory framework, the needed set-up and the perfect point of entry.

Business Case: Branding Strategy

A global manufacturer of infection control equipment wanted to enter the consumables business. A former chemical industry executive opened her network, drafted and verified business cases and designed a business model to enter the European market within the coming six months.

Business Case: Best Practice

A leading manufacturer of orthopedic implants asked us to support them in streamlining their complaint handling processes for the EMEA Region. A former automotive lean six sigma consultant worked with the client’s team to identify the regulatory challenges, redesign the processes, trigger change requests and train the trainers.

Business Case: Similar Device Analysis

A leading health care company needed to be able to compare and trend adverse events per product family and similar devices based upon Reporting Requirements & Requests for Clarification from Competent Authorities. Our business analysts supported the client by analyzing and structuring SAP data for more than 65’000 products. Within 12 months all devices where categorized and integrated in the system.

Business Case: Compliance Improvements

A leading global manufacturer of orthopedic implants was about to roll-out a worldwide initiative to improve its compliance with the latest regulations. NZ set-up a team of 8 consultants which supported the client for more than one year to meet the project timelines and goals. The team comprised a program manager, project managers and subject matter experts from different fields.

Business Case: Packaging Engineering

A global health care company ask NZ for expertise in implementing product specific labeling configurations and evaluating new manufacturing processes. A seasoned consultant got involved and helped the client by analyzing, improving and writing SOPs, leading and assisting projects and handling CAPAs.