Drug impurity profile is not a technique routine. So is the ideal project that a sponsor can externalize to specialized analytical contract laboratories.
We offer full control over the entire process of impurity identification, isolation and characterization.
Obtain relevant data, collect and interpret all physicochemical parameters and structural information needed to compile and submit an IND issue. Complete support for preparation of CMC, IND, ANDA. Support for API companies as well as Drug Products. Methods development and drug-excipient interaction.
Help costumers in the fine tuning of acceptance criteria and critical quality attributes: Identity, purity, quality, potency or strength and impurities during the course of product development.
The appropriate quality level to meet current regulations could be different in the different stages of the product process development. We choose the optimal level of assurance to meet your goals in a timely and cost-effective way. At the high limit of quality requirements we can conduct full compliant ICH method development. We offer:
- Method development plan definition
- Background information gathering
- Laboratory method development, including sample preparation.
- Generation of test procedure
As a capability that distinguishes us from other companies, we have the equipment and the ability to manufacture batches of placebo and even drug product for creams, ointments and gels.This hugely accelerates our pace of method development and validation. A resource greatly valued by our clients.
The type of validation program required depends entirely on the particular methods of the clients and its proposed applications. We help them with the best definition of the protocols to conduct studies that clearly solve the needed requirements. Typical analytical methods that need validation include:
- Residual solvents
We can conduct full compliant ICH and beyond.
Chemical Stability should be one the first concerns in the timeline of product development. We offer a full variety of stability tests trying to use a generic approach for stress testing.
We have a dedicated team for the development of drug product formulations specialized in:
- Injectable products.
- Oral, nasal and ophthalmic solutions.
- Creams, gels and ointments.
Our services range from an initial excipient compatibility study to a full fledge dossier including all requirements of the CMC section with the exhibit batches manufactured under our supervision either at your facility or at any third party manufacturing facility.
The deformulation analysis of a product, also known as “reverse chemical engineering”, is the process of analytically analyzing a formulation of a material or product to separate and determine the specific identity and exact amount of its components (both active ingredients and excipients).
This service is often used to replicate existing products, obtain detailed information about competing products, product brands, detect discrepancies in batch-to-batch products, and troubleshoot complex product failures.
Deformulation services can be used to analyze and reorganize a wide variety of products, from solid oral forms to injectables, through topical formulas and even controlled release products.
We collaborate with very different type of sectors that need analytical support in their projects: pharmaceutical, chemical, agrochemical, agri-food, veterinary industry…
Share with us your needs and you will find a close collaboration and cost-effective and timely results oriented partner.
We have wide experience in:
- Physicochemical drug characterization.
- Impurity Profiling isolation and chemical characterization of impurities.
- HPLC, UPLC method development and validation strategies.
- ICH compliant analytical drug development.
- Stability studies.
- Regulatory Support: Drug Product and Drug Substance.