Our comprehensive, phase appropriate analytical testing approach helps you prepare your product for a successful filing, with a seamless customer experience at every stage. We offer far more than a testing service; our experts help you build your analytical road map with holistic solutions and a tailored approach, backed by over a century of experience and a thorough understanding of complex, evolving regulations.
Analytical method development & validation
Our analytical services ensure compliance with the most up-to-date USP guidance as well as the rigor of revised regulatory guidance such as ICH and ASTM. Utilizing scientifically justified decisions, methods are developed following a risk-based approach encompassing the life cycle of your product and intended use. We have supported the development and validation of 300+ methods.
Raw material testing
Our raw material testing services are adapted to your needs, helping you verify the safety and quality of your product. We execute most USP compendial testing and use a variety of analytical methods and tests, tailored to your unique concerns and considerations specific to your product.
Stability testing & storage
To ensure safety and meet regulatory requirements, your stability testing services characterize your product’s shelf life under diverse conditions. We have the following conditions available for ICH storage: -20° C, 5° C, 25° C/60% RH, 25° C/75%RH, 30° C/65%RH, 30° C/75%RH, and 40° C/75%RH as well as temperature cycling. Other conditions available upon request to meet the unique needs of your product.
Our state-of-the-art laboratories and experienced scientists are equipped to handle all aspects of stability studies:
- Real-time, accelerated, and intermediate stability studies following regulatory, ICH guidelines, and custom protocols
- Advanced environmental chambers calibrated for various temperature and humidity conditions
- Continuous monitoring utilizing the latest technology
- Robust analytical testing to accurately assess the stability characteristics of your products
Extractables & leachables testing
Compounds from your combination product’s container closure system, delivery system, containment system and packaging that leach into your drug product can be a safety risk. Kindeva uses a wide range of analytical equipment, including GC, GC/MS, headspace GC/MS, UPLC, and high-resolution accurate mass (HRAM) LC/MS/MS, to identify and quantify extractable and leachable compounds.
Container closure integrity testing
- Expertise and multiple techniques as outlined in USP <1207> deterministic testing
Elemental impurity testing
- ICH Q3D Elemental Impurities – Scientific Guideline, USP <232>
- Testing of elemental impurities ensures that your product complies with the ICH Q3D Guideline for Elemental Impurities, demonstrating control of elemental impurities that are either intentionally or unintentionally present due to your product’s raw materials and manufacturing processes.
Analytical expertise across delivery formats
Across a wide range of drug delivery platforms, we integrate drug and device development to realize better outcomes. Our analytical chemistry and testing services, alongside our expertise across all stages of combination product development and manufacturing, provide unmatched support for your therapy.
Pulmonary
With a deep understanding of and background in respiratory drug delivery as the inventors of the first pMDI, we offer a comprehensive range of inhalation analytical services. This includes bioequivalence and appropriate clinical phase development testing from formulation to life cycle management for low-GWP propellants.
Services include:
- Raw material testing
- Formulation and device feasibility service
- Assay and impurity method development and validation
- Performance and functional analysis
- Elemental impurities
Nasal
Our proven track record of approvals in the U.S. and European markets positions us to guide your nasal product’s analytical approach.
Services include:
- Raw material testing
- Formulation and device feasibility service
- Assay and impurity method development and validation
- Performance and functional analysis
- Elemental impurities
Injectables
We deliver unrivaled know-how in the injectable delivery space, building your analytical road map for these complex products in an ever-evolving and in-demand market.
Services include:
- Raw material testing
- Assay and impurity method development and validation
- Extractables & leachables
- Container closure integrity
- Performance and functional analysis
Intradermal
We are pioneers in the emerging microneedle array patch space, setting the standards for analytical methods. Our testing capabilities span critical quality attributes (CQAs).
Services include:
- Physical: Microscopy, adhesion testing, tensile testing, package integrity, CT scanning
- Biological: Plate reader/ELISA, VaxAray, biocompatibility, ex vivo skin models
- Chemical: Content and content uniformity (HPLC with various detectors, GC), impurities (MS), release rate, aggregation (HPLC-RID), extractables/leachables
- Microbiological: environmental monitoring, product testing
Transdermal
Kindeva Drug Delivery has more than half a century of experience and the capabilities necessary to provide analytical support for your transdermal product, through every stage of development.
Services include:
- Raw material testing
- Method development and validation
- Extractables & leachables
- Performance and functional analysis
- Feasibility and compatibility
Looking for something else?
Contact our analytical testing experts to find out more about how Kindeva can serve you.
Our commitment to quality
Our team has a demonstrated track record of compliance with regulatory bodies worldwide and Quality by Design (QbD) principles are central to our processes. In line with Kindeva’s commitment to quality, our analytical services are performed in a cGMP compliant, FDA-registered facility with an audit completed in April 2024. We are also DEA-licensed for Schedule I-V controlled substances.
Support your combination product’s path to market
Leverage our industry-leading capabilities, century of analytical experience, and wide range of services to ensure your product meets regulatory requirements throughout its entire life cycle.