How TAPI Scientific Support Team uses its expertise to support the needs of its customers
By Revital Lifshitz, Senior Manager, Scientific Support, TAPI Commercial
Some of our best customer-care practices are developed through experience, planning and close collaboration with our customers. Others have been created to enable TAPI to work in closer partnership and co-operation with our customers, and fine-tuned over the years. Some are the response to changes in market regulations or compliance, and one…well one just took on a life of its own and started growing. We are talking about TAPI’s Scientific Support Team (ScS).
To be really close to our customer, we become the customer
TAPI’s ScS works as closely with our customers as they do with their internal colleagues. It makes a lot of sense because the projects undertaken by the ScS team are usually very complex. To really understand and help our customers we need to have our top R&D experts working with our customers, especially during critical phases such as introduction of new API’s and development, representing our customers to optimally service their needs as they arise.
The Scientific Support Team is a small team of experts, all chemists with years of experience working in R&D and customer support, who engage with our customers to support them from selection through and including commercialization of a product. Among others, there are 5 areas that are critical to the success of our customers API development as outlined below and are part of the amazing support our global ScS team provides.
Accommodating your pipeline needs
The ScS team works as a liason between the customer’s needs and TAPI’s global R&D team in technical matters related to API in order to support formulation needs for successful submissions. The ScS team accompanies our customers during the development stage and then support all their needs through to submission, reducing administrative time and helping to accelerate the submission process. The ScS team works with our key points of contact at our customers in order to best implement and execute their product’s market launch. During this process, we are able to represent the customer inside TAPI, and to explain the customers’ requirements and challenges to the various global units in TAPI including R&D, RA, production, site solid-state experts and site QA . The result is a clear understanding and dialogue between the customer's & TAPI's professional units.
Simplifying your API supplier selection
As customers know very well, approving an API supplier for development is a complex and time-consuming process. TAPI’s ScS team is available to our customers to from the initiation of the selection process, providing detailed feedback on questions regarding initial samples provided by TAPI and helping to align on the necessary chemical and physical quality specifications. Once this has been approved the formulation trials take place by the customer.
Our ScS team is typically deeply involved during this stage of development, facilitating R&D to R&D discussions to assure our customers go to their bio studies with the best product possible from TAPI. This collaboration is designed to close any gaps related to physical and chemical characteristics of the API.
Enhancing customer satisfaction
Due to the complex nature of our industry, anomalies will occasionally occur. When these anomalies occur, our ScS team are there to provide support to identify the root cause and support in the necessary CAPA (Corrective Actions, Preventive Actions). The ScS team can join our customer’s team to review the issues in detail. Our ScS team will investigate why the customer is having an issue and suggest solutions including method harmonization, setting different impurity limits or many other solutions. The bottom line is our ScS team is here to support our customers in an expedited and comprehensive way to assure an optimized experience working with TAPI.
Sourcing the best Alternative Source
When a customer decides to choose TAPI as an alternative API provider (e.g. – Alternate Source) they needs to minimize their investment in R&D by submitting the same formulation as that of the original source.
At this stage, the most common parameter that needs to be adjusted is the Particle Size Distribution (PSD). The ScS representative adds significant value to the process by coordinating the PSD grade development and PSD method harmonization, while conveying the customer's requirements to TAPI's R&D experts, resulting in samples for preliminary dissolution trials.
Another parameter that may need to be adjusted during the alternate source process is related to storage conditions. If TAPI's regular storage conditions differ from those of the customer's 1st source, the ScS representative coordinates a stability study of different storage conditions to ensure that TAPI's API is stable and complies with the customer's storage conditions.
Regulatory issues – regional knowledge
TAPI has a long tradition and a wealth of experience in supporting our customers with regulatory issues around the globe. This support is also part of the support service provided by ScS, most specifically before a submission is made to the authorities. The ScS team takes part in kick-off meetings between TAPI Global RA team & the customer’s RA team before a submission takes place. This is in order to achieve a full alignment between both sides in regards to specifications, analytical methods, genotoxic impurities etc. ScS also offers support whenever there is a need to overcome specific gaps that relate to special regulatory requirements (especially in unique markets like Japan & Latin America). Regulatory issues vary from market to market and our ScS team are currently working closely with our customers and offering RA support in the following markets: US & India, Europe, Latin America, Japan and Korea.
Lets talk R&D to R&D
The TAPI ScS team resources are focused on projects, which will bring the highest value to our customers and their business and ensure a long-term relationship with customers. Our desire is to strengthen our R&D services and offer true R&D-to-R&D support for our customers. We have evolved into a unique service offering scientific support that goes beyond anything seen in the API industry. ScS has expanded and to meet demand. If you are a global or local generic pharma company looking for the closest professional support from an API supplier to take you all the way from selection to commercialization and if you operate in the following markets US & India, Europe, LATAM, Japan and Korea …why not get in touch?
About the author
Revital Lifshitz has a M.Sc. in organic chemistry from Tel Aviv University, and has been working at TAPI for 21 years. She is currently the senior manager of TAPI Technical and Scientific Support (ScS) Japan and Korea, and has been in that position for 7 years. Her previous roles in TAPI have included; Customer Service Manager at TAPI International Sales Office, TAPI Contract Development Manager, Chemical R&D Project Manager and R&D Researcher.