Clients using KABS for quality controls by pharmacopeial methods receive a Certificate of analyses within 5-7 days. Typically, a new client should contact us by telephone, e-mail or fax to describe the specific requirements. When relevant, we prepare and sign a confidentiality agreement before considering your requirements. A quotation is issued within 48 hours. Upon acceptance, a quality agreement is signed, as required by Health Canada and the FDA, and the work can start immediately.
Rush orders for less than 5 days are also accepted. Surcharges for rush orders may be applicable depending on the volume and type of resources we have to deploy in order to deliver in time. For example, a 200% surcharge would apply for an overnight rush order for testing a single sample requiring night time overtime of senior staff using a LC-MS. On the other hand, if our clients submit a rush order while we run the same type of samples, no surcharge would apply since the rush order does not imply additional expenses for KABS.
Analytical R&D and validation
Analytical R&D and stability projects are usually related to drug discovery programs or generic formulation projects. Analytical R&D services provided by KABS can be performed either independently or in close collaboration with your staff. Reports are presented either as self-supported files including all the requirements of the cGMP (Current Good Manufacturing Practices) guidelines (certificates of validation, calibration, training, etc.) or in a simplified format with the supporting quality assurance documents available in our files.
The complexity of drug development programs requires accurate communication with your scientific staff and the establishment of detailed contractual agreements based on mutual understanding of all technical, scientific and regulatory goals of the projects. We consider e-mail, fax and telephone communication sufficient for the management of modest projects. On the other hand, we usually initiate a drug development program by a visit to our clients in order to meet with all individuals involved in the program.
We use mainly the Agilent 1100 and 1200 instrumental platforms, with virtually all types of detectors. When conventional HPLC fails, we use UPLC, capillary electrophoresis systems (chiral separation, isoelectric point of proteins, proteins MW determination by Ferguson plots) or Sciex LC-MS-MS model API 4000. However, if a new client desires to use different platforms to validate and run their methods for future transfer to their QC laboratory, we can purchase or rent the appropriate instrument for the duration of the program.
We use walk-in qualified and validated incubators set at conditions recommended by the ICH. Our clients may rent space in these incubators and have the samples tested at their lab or at KABS. New clients interested in using our stability testing services should contact us to submit their specific requirements. KABS then submits protocols and quotations. Upon acceptance, a quality agreement and commercial contract are signed and work can start.
Product development and pilot manufacturing
Our four pilot plants are equipped to produce virtually all solid/semi-solid, and liquid/lyophilized dosage forms. Over the years our stable, dedicated and experienced staff has been developing and manufacturing complex formulations. The complexity of all aspects of a successful pilot manufacturing service requires a high level of communication with our clients and their clinical planners. Please contact us as early as possible in your development planning.