You’re low on time or resources, particularly when you need a specific instrument for a specific job. As not all instruments can do any test, you need a specific test that requires a specific instrument with a validated method that can give quality results. This is what gets your drug to market. Small company, big company, doesn’t matter – you don’t want or need the hassle of knowing every little thing about every single procedure and gaining verification for that device, particularly when the device alone will break your budget. You really just want the needed information to provide data to the FDA to get your latest development to market and keep it there with as few issues as possible.
Don’t Blow the Budget
You need the overall particle acceptance rate, what instrument can provide it consistently, effectively and in a timely matter. This is the required data that is important, if not critical to getting that pharmaceutical to market. You don’t want there to be any data holes causing repeat analysis or the instrument to break down. Repeating data runs increases costs and breakdowns cost you time. If it does breakdown you need a backup, which can double the verification costs of a batch if you are maintaining this equipment on your own.
A commercial laboratory often maintains more than one piece of key equipment, as PTL analysis services does. Our laboratory can keep testing moving and can give you a way to keep control and get the info you want without your own time allocation and expense. You need to make sure your latest medical marvel is consistently the same without breaking the bank. Our analysis services can decrease your expenditures, resolve your particle issues, and provide you the required information you’re wanting/needing.
High Quality Instrumentation
Pharmaceutical companies maintain and improve their new market medicines in conjunction with an independent Quality Assurance Unit. Qualifying a variety of instruments can be expensive. This expense increases, as once qualified, keeping it running can be expensive. FDA inspections for the equipment can add to the expense as FDA requirements can be costly and time consuming, decreasing the time and money meant for assaying medical batches. Your job is to get the results and fix composition if needed, but you don’t really want to have your hands on the devices or develop the procedures. Our comprehensive particle size and characterization lab means we can handle almost any product in development or after market.
Having duplication of key qualified instruments also keeps costs low through decreased downtime to verify new instruments while the regular instrumentation is being repaired. Repairs can destroy budgets while re-verifying an instrument can drastically increase time to get therapy to market. If you are the one required to maintain verifications and data you are vividly aware of the digital age we are in. In the digital age, we are all required to know and be verified more with analysis devices storing and communicating great volumes of data requiring security and security plans.
With a commercial laboratory, resources can be used wisely to get procedures created, producing consistently to gain and maintain FDA rules to keep costs low as possible. Our analysis services decrease your expenses by maintaining functional devices and appropriately equipping them with what they need to keep them qualified and ready for cGMP use.
Staffing - The Budget Buster
Personnel can be one of the most expensive items in a laboratory with instruments winning second in expenses. Focused personnel in a commercial laboratory gain an extra sense of operative versus what is not quite right, are impartial to the protocol in use, and desire for the protocol to succeed. These factors lend greater success in quality to the data given to the FDA. Accreditations are ongoing and expensive to maintain - with few staff members trained, experience can be difficult to get making them expensive. There are other ways to gain required particle information without having to spending your money and time on the details.
A commercial laboratory such as PTL maintains its accreditation without your staff’s time and have decades of experience. PTL has the instruments, personnel and experience to provide that data consistently and effectively for you.
Manage it yourself? Why bother? Have PTL provide results for you. Our services can serve as your accredited cGMP compliant laboratory, ready and available when needed. Contact us – we’ll take care of your analysis, so you don’t have to.