Analytical testing for pharmaceutical intermediates, Active Pharmaceutical Ingredients, & formulated drug products.
SK pharmteco (SKPT) offers SmartTest, an analytical chemistry platform for API, drug substances, and fine chemical manufacturing. SmartTest allows for complete support within CGMP guidelines. It can be utilized as a standalone service or with other SKPT Platforms.
provides the consistent integration of testing capabilities for highly potent and cytotoxic compounds,
controlled substances (I–IV), and raw materials testing.
All
of
our p consistently integrates testing capabilities for highly potent and cytotoxic compounds,
controlled substances (I-IV), and raw materials testing.
Our platforms are designed for robust, scalable, and plug & plug chemistry, combining engineering technology
with analytical expertise. Therefore, our offerings can support clinical to commercial-scale capabilities,
incorporating expertise in route development, which translates into not having to outsource any processes. All this
allows fewer steps, faster turnaround times, increased efficiency, and lower costs. Finally, all of this is done under
CGMP guidelines are within the strictest regulations and safety protocols at a US-based facility. Platforms are designed for robust, scalable, and plug & plug chemistry, combining engineering technology
with analytical expertise. Therefore, our offerings can support clinical to commercial–scale capabilities,
incorporating expertise in route development, which translates into not having to outsource any processes. All this
allows fewer steps, faster turnaround times, increased efficiency, and lower costs. Finally, all of this is done under
CGMP guidelines are within the strictest regulations and safety protocols at a US-based facility.
What is our specialty?
Our technology platforms are designed for robust, scalable, and efficient processes through the combination of engineering, chemical, and analytical expertise.
The SmartPlatform Portfolio provides the consistent integration of capabilities to support development and manufacture from lab to commercial scale. Our expertise in route development and manufacture at all scales using unique technologies means fewer steps, faster turnaround times, increased efficiency, and lower costs. SKPT offers complete manufacturing solutions under CGMP under stringent regulations and safety protocols.
Our offerings can support clinical to commercial-scale capabilities, incorporating expertise in route and method development, all available in-house.
This allows fewer steps, faster turnaround times, increased efficiency, and lower costs. Finally, this is done under CGMP guidelines at facilities worldwide, under the strictest regulations and safety protocols.
SK pharmteco’s SmartTest
Testing capabilities for active pharmaceutical ingredients (APIs), including highly potent and cytotoxic compounds, controlled substances (I–V), and raw materials testing.
Plug & Play
Each technology platform is fully integrated within the SKPT SmartPlatform Portfolio. As a result, each technology can be transferred and seamlessly integrated across all our facilities. All data is organized, managed, tracked, and maintained to ensure CGMP compliance and transparency with our customers.
Productivity & Scalability
SmartTest is optimized to provide analytical testing in a reliable and scalable manner. SK pharmteco’s SmartTest Platform can address your needs for analytical support with early phase programs. We can build a strong analytical foundation from inception; with the product lifecycle in mind, focusing on phase-appropriate method development and validation and early introduction of forced degradation studies to assist in the development of chromatographic methods that are mass-spec compatible.
Time- & Cost-Savings
Designed to be efficient and cost-effective, minimizing production hours and increasing output, SmartTest was specifically created to streamline analytical development and scaling. Integrating our analytical expertise with technical and process innovation provides time and labor-efficient results. Our decades of experience and expertise in method development reduce the need for unnecessary steps – or avoiding the omission of crucial ones. Utilizing SmartTest as your dedicated analytical service frees up critical resources, allowing you to focus on your product.
Analytics
Our technology platforms are closely associated with data analytics to provide our customers with Key Performance Indicators. SKPT is moving towards digitalization to provide increased value to our customers as well as monitor and improve all our processes.
Robustness
The term robustness within analytical chemistry refers to a method’s ability to meet its analytical requirements (system suitability requirements) despite small variations of the method’s parameters, such as discrete changes to a column or sample tray temperature, percent organic modifier, flow rate, or detector wavelength. This capability is typically built into the method during method development. Whether it is only outsourcing analytical testing or utilizing multiple SKPT Platforms, SmartTest plans for method robustness and resiliency across the entire product’s lifespan.
Expertise
- Material Science (PXRD, DSC, TGA, DVS, surface area)
- Particle Engineering (including flow properties)
- Spectroscopy & Spectrometry (ICP-OES and ICP-MS, NMR)
- Microscopy (optical and scanning electron)
- Chromatography ((U)HPLC and GC, including mass spectrometry).
- Method Development
- Method Validation / Transfer
- Comprehensive Analytical Release Testing
- Stability Program
- Reference Standard Qualification
- Compound Characterization
- X-ray Powder Diffraction Analysis
- Elemental Impurities – USP<232>, <233>, ICH Q3D
- Nitrosamine Impurities Testing
Safety
All SKPT facilities adhere to the motto “Safety First, Quality Always.” These two essentials are at the heart of our process development and manufacturing capabilities. Regardless of the chemistry, our experienced team of technical professionals always spends the necessary time to assess the associated hazards with the process to ensure a safe scale-up at all our plants.
Regulatory Support
Our Quality/Regulatory team is experienced in interacting with regulatory agencies worldwide to support our customers with their filing. Through process development reports, critical parameter evaluations, or site audits, our chemists, engineers, and regulatory experts are experienced in bringing your product from development to commercialization through successful validation. Our track record with the regulatory agencies is impressive. Our success rate in Pre-approval Inspections ensures that validations and product launches occur without any regulatory concerns. Our history even shows a significant number of inspections being waived due to the high quality of our systems.
Project Management
Our Project Management Group has end-to-end responsibility for the assessment and execution of your program. The PM team will work closely with you to understand your needs and objectives and develop a plan to initiate and execute project deliverables. Once a project is awarded, a Project Manager will be assigned who will become the key point of contact for the Customer. The PM will be supported by an internal integrated cross-functional team responsible for project delivery. We will work with you to agree on the optimum arrangements for managing all elements of your project and enable the highest level of collaboration and problem-solving across technical groups. Timely, accurate, and transparent communication is vital to the success of our projects, and we maintain the highest levels of integrity in all our activities. Our ultimate goal is to deliver your project on time and right the first time.
