What we do
What we do
What we do
We are handling the technological adjustments at the new production site ourselves and designing your technology transfer so that dossier adjustments remain minimal. This way, we ensure a quick and risk-minimised production start for you following successful validation.
In parallel, we are actively bringing the manufacturing process up to the latest regulatory standards and efficiently optimising the production flow.
Furthermore, we handle the transfer of your analytical methods to the new service provider – competently, with a practical approach, and with a full focus on GMP compliance and budget adherence.
As experienced QA, MSAT and Manufacturing experts, we will hands-on augment your team, ensuring your projects are delivered on time, cost-effectively, and with minimal GMP risk – we are not a consultancy, but your reliable implementation partners.
We are comparing the two manufacturing sites or laboratories regarding equipment, know-how, and previous experience. You will receive a precise overview of the key differences and whether there are any risky steps in the manufacturing process or risky analytical methods.
Basing this on the existing risk assessment, we will investigate for you which processes and methods require special training and what acceptance criteria can be established. We will also incorporate any additional necessary tests into the overall plan and create a realistic timeline.
All planned tests will be documented and analysed after their completion.
The comparison with the met acceptance criteria ensures that the technologies and methods have been successfully transferred. This results in two equivalent laboratories and equivalent, validated production sites.
We've made our mistakes before. We'll save them and ourselves from those. All team members are seasoned managers with many years of experience in Manufacturing, Supply Chain, Quality, and Regulatory. We know cost pressure and result pressure from our own experience.
For a production transfer, we are actively searching for and evaluating several potential contract manufacturing organisations (CMOs) and are specifically conducting a technological gap analysis.
We precisely analyse how well a contract manufacturer fits the specific requirements of your product – regarding batch size, special equipment or manufacturing authorisations such as for narcotics, for instance.
We assess the production process in the dossier and make an informed decision on whether a transfer to a specific contract manufacturer is sensible and feasible.
Once technical feasibility is established, we will conduct a detailed risk analysis to identify and address key GMP-relevant risk factors at an early stage (especially for technological adjustments and dossier changes). This is a dynamic assessment that we will continuously refine and implement throughout the transfer and detailed planning process.
Our team of experienced QA, MSAT, and Manufacturing experts acts as an extension of your company – we are not merely consultants, but pragmatically implement solutions hands-on. We supplement your team only where additional support is needed. This keeps teams lean and agile with costs under control.
We integrate all relevant areas into our assessment: external laboratories, suppliers of aids and auxiliary materials, contract packing, warehousing, and the entire logistics chain.
This is how we ensure that budget and GMP compliance are optimally balanced.
Our risk analysis enables you to make a realistic assessment of whether the production transfer is feasible or if complex measures such as modifications or investments will be necessary.
We will keep an eye on costs and timelines and manage the process to implement your projects on time and with minimal GMP risk.
Technology transfers are relatively complex projects as they always involve several departments within a company, and in addition, multiple companies.
Every company has its own structures and ways of thinking that are not always entirely compatible. This is often referred to as “cultural differences” – yet the absolute importance of these differences is often overlooked! We speak 9 languages in our company and therefore already know some cultural differences from our daily lives.
For the planning of the transfer, it is very important to establish a common understanding first. First, we define the common goal, success criteria, and the most important steps, and then we start with the detailed work.
We are trying to support decisions with data as much as possible. This approach pays off very well financially in later implementation.
 It is rarely possible to implement a production one-to-one. Most of the time, adjustments to the production process are necessary. These adjustments are often dictated by the different types of equipment.Â
However, certain changes desired in the production process can also lead to this (for example, flexibility in batch sizes, flexibility in manufacturing plants, etc.). This also requires necessary technical adjustments. We obtain our data through carefully planned laboratory experiments or tests in the technical centre. This saves us very costly technical trials („technical batches“).
In recent years, this has been grouped under the term “AI”. We tend to use more specific terms like Design of Experiments, multivariate analyses, simulation, etc.
A few years ago, this was still commonly known under the term chemometrics.
With the data we've gathered, we create simulation models, enabling us to make good predictions for the technical implementation. This also ensures you adhere to „Quality by Design“ requirements and provides greater flexibility for later process changes.
We typically carry out the production itself and its success monitoring during process validation. There, in the risk analysis, there is again an opportunity to review and adjust the initial risk assessment. Parameter ranges that can strongly influence process flexibility are tested during validation.
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In addition to manufacturing, all affected parts of the supply chain must also be controlled. This includes analyses in external laboratories (e.g., release or microbiological controls), contract packaging, the logistics chain, and storage (e.g., cold storage). Only when the entirety has been checked and validated with stability samples do we consider the transfer successful. Our success monitoring therefore goes beyond a normal validation batch.
We relieve you and your core team for specific projects. We bring „hands-on experience“ from seasoned managers. We organise your projects as „low risk“ GMP projects, with maximum speed and within the budget framework. You minimise regulatory risks and have clear responsibilities along with a transparent organisation. You will have a highly experienced project team with high technological competence. We are 7 experienced practitioners (QA, QC, QM, Manufacturing, Data Science, R&D, Supply Chain) with additional FTEs – depending on the project scope (FTEs from 10 – approx. 40).
Transfer of technology is defined as “a logical procedure that controls the transfer of any process, together with its documentation and professional expertise, between development and manufacture or between manufacture sites”
