Analytical development: Fueling innovation
We don't just develop analytical methods – we apply a methodical and customized approach to solve the problems you haven’t identified yet. Our end-to-end analytical solutions empower your products to reach their full potential. Our global expertise spans a wide array of capabilities, ensuring your success at every stage.
Our Analytical Development Services
Our analytical development services include:
- Full-service method development: Verification, validation and seamless method transfers.
- Chromatography, covered: From liquid and gas chromatography to hyphenated techniques like GC-MS and FTIR.
- Beyond the basics: Product characterization, atomic absorption spectrometry and expertise across a wide variety of dosage forms.
Discover game-changing analytics
Day in, day out, our analytical development team is committed to solving problems and bringing your vision to life. Partner with us and discover analytical development made just for you:
- Expertise and experience: Our scientists are at the forefront of what's possible in analytical development. When you partner with us, you're tapping into a collective brainpower that sets the industry standard, ensuring your products get the absolute best.
- Comprehensive solutions: From the first spark of an idea to the final product launch, we've got you covered. We offer a 360-degree suite of analytical services that leave no question unanswered and no challenge unsolved.
- Quality without compromise: We live and breathe quality in every process. It's woven into the fabric of our company, an ongoing commitment that drives everything we do. Your products deserve nothing but the best, and that's exactly what we deliver.
- Customer-centric approach: We're in this together, and we'll go the extra mile to ensure your vision becomes a reality. Consider us an extension of your team, a partner who’s proud to stand by your side for decades to come.
Analytical strategy where you need it
Our analytical development services include:- Comprehensive project management from conception to launch
- Technical support for new product development, introduction and launches
- State-of-the-art facilities
- Technology transfers
- Sourcing strategies
- Validation
- Cross-functional validation expertise
- Digitally enhanced platforms for laboratories for end-to-end quality management
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Frequently Asked Questions About Analytical, stability and development
Does Formulated Solutions provide analytical development?
Yes. Analytical development is part of the company’s integrated CDMO service offering.
Can Formulated Solutions develop and validate analytical methods?
Yes. Formulated Solutions provides analytical-method development and validation for appropriate programs.
Does Formulated Solutions conduct stability studies?
Yes. The company maintains stability capabilities supporting development and commercial programs.
Can Formulated Solutions help establish product shelf life?
Yes. Stability programs and analytical testing can generate data supporting appropriate product shelf-life assignments.
Does Formulated Solutions use Quality by Design?
Its formulation and process-development approach incorporates Quality by Design principles to consider product quality and manufacturability throughout development.
Can Formulated Solutions optimize an existing manufacturing process?
Yes. Process-development capabilities can be used to evaluate and optimize existing manufacturing processes during development, scale-up or technology transfer.
Does Formulated Solutions develop analytical methods for liquid and semi-solid products?
Yes. Formulated Solutions develops analytical methods for liquid and semi-solid products, including creams, gels, ointments, lotions, foams, solutions, suspensions, aerosols, and nasal sprays. Methods are tailored to the product and may assess assay, related substances, degradants, and preservative content.
Does Formulated Solutions validate analytical methods to ICH guidelines?
Yes. Formulated Solutions validates analytical methods using appropriate ICH principles, with the scope of validation matched to the development stage and intended use. Confirm the specific guideline and validation characteristics with your technical team before publishing.
Can Formulated Solutions transfer an analytical method from another laboratory or CDMO?
Yes. Analytical method transfer can be conducted under a written protocol with predefined acceptance criteria. The approach—such as comparative testing, co-validation, or revalidation—depends on the method and the product.
Why can analytical testing be more challenging for semi-solids than for solutions?
Semi-solid products can contain oils, emulsifiers, and polymers that affect sample preparation and analytical recovery. Method development needs to account for the specific formulation matrix and demonstrate that the active ingredient can be measured reliably.
What physical testing does Formulated Solutions perform for liquid, semi-solid, and spray products?
Formulated Solutions performs rheology and viscosity testing for applicable products and spray or droplet characterization for applicable spray systems. Confirm the specific tests available for each product type before publishing. This FAQ does not claim that Formulated Solutions performs IVRT.
Does Formulated Solutions perform microbiological testing in-house?
Formulated Solutions performs microbial limits and preservative effectiveness testing for applicable non-sterile products. Confirm the specific tests and current in-house scope with Quality before publishing.
Can multiple wound care package sizes use the same validation and stability plan?
Multiple sizes may share some development work, but each formula and packaging configuration must be assessed. Different containers, closures or dispensing systems can change the testing requirements. Formulated Solutions works with customers to define the validation and stability scope, including whether a justified bracketing or matrixing approach is appropriate. A shared formula does not automatically make all package sizes interchangeable.
What testing can you support for wound care and animal health products?
Formulated Solutions provides analytical development, method transfer or validation, stability studies and product testing within an agreed project scope. Testing is selected for the formulation, packaging and intended market. Requirements may include appearance, pH, viscosity, active content and microbiological quality, where applicable. Specialized testing and any external laboratory work are identified during technical assessment.
Ever tried the Formulated Solutions approach?
Delivering excellence since 1999 from the forefront of innovation. Pushing boundaries and challenging the status quo underpinned by a bedrock of reliable quality. We're more than just a CDMO – we empower our clients to deliver impact with every action.