Explore with Us

To put it simply, we are problem-solvers. We are interested in getting to the root cause of problems and eliminate them. Every problem that we can overcome with our clients gives them the opportunity to progress forward. It builds resilience in their teams and their quality system to handle more challenges.

If you want to explore ways to overcome your problems and create more growth opportunities, come talk to us – we love to help!

A manufacturing facility learned that they were not ready for a PAI (pre-approval inspection). In a letter to the company CEO, the country regulator identified several key issues in their validation program and concluded by advising them to engage a consultant. That was what led the company director to contact us.

From reading the correspondence between the company and the regulator, we observed that the company had viewed the issues differently from the regulator. For some issues, the company had misinterpreted the regulator’s concerns.  For others, they had followed practices that were recommended by practitioners who were not familiar with requirements that were specific to the country that the company intended to export the products to. We highlighted what would be deemed as “red flags” to the regulators, what we could do to verify that the concerns were true, and how to manage them.

With the client’s agreement, we conducted on-site gap assessments. These provided the opportunity to help the client understand the specific requirements that they had not been complying with. The assessments also allowed us to identify the root causes to the non-conforming items.

This was followed by a facilitation session to get the team to create the action plan to close the gaps. The aim was to build their commitment  by helping them to understand the “Why” and “How” elements of the action plan.

We finished with providing technical resources to review the actions that were carried out, and also made provisions to bring experienced practitioners to train them in areas that were beyond the capability of the client’s team. The entire exercise was designed to build the competency of the team, which lacked experience on managing inspections. By working alongside with them and showing them the thought processes, the confidence of the team was much improved after the entire process.

Whenever they create a product extension for their customers, our client has to review the strategy for managing the changes. In one situation, they faced a series of back-to-back changes: manufacturing location change, material change, design change, packaging change. All of that were needed to deliver a new product. Can they create a cost-effective validation program for that? We were roped in to review their sterilization validation program. From assessing their past validation and requalification data, we created a lean sterilization validation strategy to support the changes without affecting the product sterility

A surgeon created a device prototype that can be used to improve the effectiveness of a surgical procedure and shorten patient recovery time. He wanted to send it for performance and biocompatibility studies. As the final product would be a sterile device, the prototype was to be sterilized prior to sending it for testing. As he didn’t know which sterilization method to use and how to develop the sterilization process, he contacted us.

In the first meeting, we shared about the regulatory requirements for preparing prototype samples for various purposes, which included preparing samples for the different phases of clinical trials. When he had understood the requirements and the approach, we arranged for a design review of the prototype and a review of the manufacturing processes. When all the required information was gathered, we proposed the sterilization methods that were suitable for the design and the implementation strategy for each sterilization method. The pros and cons of each sterilization method were presented to help him understand the trade-offs.

As a result, he could define the requirements for making the prototypes more clearly. This improved his working arrangement with the contract manufacturer to produce sterile prototypes for further studies.

This young team has to upgrade their laboratory operations to provide more value added services to their customer. We got involved by assessing the gaps first, then developed the overall implementation plan for them. With our experience in GMP analytical laboratory management, we created process flows and operational procedures, and provided training for the team members to upgrade their laboratory operational and technical skills. With that, they were equipped to provide better testing support and assist in failure investigations.

What was most satisfying to us was to see their transformation from a team with insecurities to a team that was more confident to take on the new challenges from their customer.

The third-generation owner of a local company wanted to bring his grandfather’s products to more countries in Asia. To do that, he wanted to transform his family-run production line to one that can meet the regulations of the new markets.

In the first dialogue with him, we explored the various challenges for his goal. One deliverable was to build an integrated quality management system for the product development and realization activities, in an ISO 9001 framework to meet the varied market requirements for the products. With that as a foundation and enabler, he was more ready to work with the distributors to register his products for the new markets.

It was one step closer to helping him realize his dream of seeing his grandfather’s inventions on the shelves of pharmacies in more countries in Asia

It was a good idea – to qualify a processing material that would cost a fraction of the original. But as the qualification work progressed, the results were baffling the project team, so they contacted Audentiq. Audentiq pieced together the situation and showed gaps in the process development and validation work of the supplier. As the relevant GMP requirements could not be met, the direction of the project was shifted to another processing material.

Our client hired a new project leader. His first project was to qualify a new sterilizer but he had little sterilization experience.

To help the client, we created a customized training program for the new leader and his team, which was based on the project requirements and the quality system of the company. In that way, each training session led the team to create a specific deliverable for the project, including a project dashboard and communication package for the project stakeholders.

As the team progressed into the technical details of equipment installation and qualification, we supported with validation data review and advised on unexpected developments. The new sterilizer was qualified on time. As a show of confidence in them, our client commissioned the same team to run another sterilization project later that year.

This pioneering team is in a new and exciting territory. Their product is novel and so is the manufacturing line. They are playing “catch up” with filling headcounts and maintaining the pace of development work so that they can release the products on time.

With many goals to meet and limited resources, the Audentiq team was roped in to assess risks, develop mitigation plans and develop suppliers. When the headcounts were filled, we worked through the handover with the staff so they can transition confidently into the work with little lag time.