CUSTOpharm services include:
· Product Development
CUSTOpharm’s development expertise allows our clients to focus on non-clinical, clinical, marketing and other aspects of drug development and distribution. Employing our services decreases our clients need to utilize valuable resources on product development activities such as analytical validation and formulation development. At CUSTOpharm, we can facilitate development with our clients’ current laboratories or we can assist our clients in identifying appropriate laboratories to ensure that project timelines are met, and that our clients’ needs are met.
· Sourcing of Product Manufacturing
CUSTOpharm has established strong relationships with many contract manufacturing organizations (CMOs) both in the US and abroad to enable our clients to effectively manufacture a variety of dosage forms whether for use in clinical trials or commercial production. We specialize in injectable dosage forms, including suspensions, lyophilized and cytotoxic compounds. Additionally, we also have relationships with oral, ophthalmic, otic and nasal CMOs. These relationships enable our clients to meet aggressive timelines.
· Technology Transfer
During the progression of clinical trials, a drug product will need to be transferred from the clinical supply site to a commercial manufacturing site. Additionally, financial or other factors may require that a product be transferred between manufacturing facilities. CUSTOpharm has established a systematic approach to ensure an effective technology transfer between two manufacturing facilities while avoiding disruptions in clinical or commercial product supplies.
· Regulatory Support
CUSTOpharm continues to be a pioneer with eCTD submissions. To date, CUSTOpharm has submitted more than 50 submissions in the eCTD format. We were the first to submit an ANDA completely in the eCTD format and have been preparing submissions in the eCTD format for more than four years.
We realize that there are other companies that prepare electronic submissions, some of which charge exorbitant fees that are not affordable for a small pharmaceutical company. CUSTOpharm has developed an eCTD submission process that is both cost effective and does not utilize costly and complicated software. This approach to submissions does not utilize a “black box” approach but rather customizes each file written for our clients’ products. This ensures our ability to quickly troubleshoot problems if they arise. The end product is a FDA compliant validated submission in the eCTD format. Our “big picture” approach is most applicable for our regulatory solutions because we always keep a marketable product as our ultimate goal.
CUSTOpharm rapidly integrates the dynamic FDA and ICH trends as they pertain to the eCTD submission and requirements thereof. In addition to submission preparation and assistance, our services include SPL label preparation and we anticipate utilizing the electronic gateway by mid 2008. We understand that some organizations have difficulty utilizing electronic submissions and/or the CTD format. We work with our clients to explain procedures and develop a solution to meet the clients’ needs and the FDA requirements.
· Project Management
CUSTOpharm has extensive experience in project management. This service is included with all of our development and regulatory services. Our clients receive status updates of their projects via reports and Gantt charts. Our clients are updated on the status of their project(s) and aware of any project delays, if applicable, as they occur.
· US Agent Service
Our US Agent service provides a pathway for foreign pharmaceutical companies interested in expanding beyond local markets and desiring to enter the US market. CUSTOpharm works with our clients to ensure compliance with US cGMPs and oversees the regulatory process.
For foreign generic companies, the main advantage obtained by working with CUSTOpharm is that a commercial marketing partner does not need to be selected prior to the submission process. As approval nears, a marketing partner can be selected. This additional time benefits our clients ensuring they identify the best marketing partner and ultimately the best possible price for their product.
· Contract Manufacturing
Being a customer focused company CUSTOpharm has evaluated the various options available for the manufacture of the sterile products. Based on this evaluation, CUSTOpharm has identified a cost effective opportunity whereby smaller and virtual pharmaceutical companies could have access to contract manufacturing at prices similar to companies that possess their own manufacturing facilities without the burden of the large overhead associated with maintaining a sterile facility. Please contact us for additional information regarding this new service.
· The CUSTOpharm Program
The CUSTOpharm Program is our turnkey program combining all of our services described herein. Our clients select a generic product that they would like to sell commercially in the US and/or abroad. CUSTOpharm works with drug substance suppliers and CMOs to determine the best pricing for development and costs for commercial production. This allows our clients to determine if the product is commercially feasible before spending significant funds.
CUSTOpharm oversees the analytical and formulation development, manufacture of the stability batch(es) and stability testing. CUSTOpharm then prepares and files an ANDA submission in the eCTD format with the FDA. The final product of this service is an approved ANDA. If desired, this service can be extended to oversee the process validation of the drug product. The degree of client involvement in the product development and regulatory process can be modified to suit our clients’ needs.