We offer end to end technical and administrative services for all aspects of pharmaceutical operations.
Whether you are in the drug innovation, manufacturing or distribution business, our specialists can guide you in identifying an optimal solution for your needs.
Certain procedural steps are followed to ensure complete confidentiality of our client's potential projects.
If you would like to initiate a working relationship with Allay Pharmaceuticals, please submit a request for Non-Disclosure Agreement.
Solubility Study
API Stability
Excipient Interactions
Prior to the development of any major
dosage form, Allay's product development scientists perform critical
experimentation to determine the physiochemical characteristics of
the drug substance with the goal of designing optimum drug delivery
system. Basic pre-formulation studies include:
Solubility determination
pKa determination
Partition co-efficient
Crystal properties and
polymorphism
Practical size, shape and surface
area.
Chemical stability profile.
Any additional special studies are
conducted depending on the type of dosage form and the type of drug
molecules.
Complex Method Development
Method Validations & Transfers
Testing of Raw Materials & Finished Products
Stability Storage and Testing
At Allay Pharmaceuticals, we offer a
comprehensive package of analytical services to support product
development and marketed product activities. Our expert scientists
have years of industry experience ranging from developing methods for
early candidates, to New Drug Application submission support. We
assure that the methods that we develop are robust, efficient and
cost effective. Most of our proficient scientists come from
contract pharmaceutical service background and have the experience to
tackle the toughest method development challenges. Once methods are
developed, we ensure the methods can be appropriately validated - in
our laboratory or yours.
Our scientists stand ready to offer
technical assistance in case you choose to transfer methods to your
own laboratory. Routine testing of raw materials, finished products
and stability samples are a part of our services for product
development support. Our laboratories are equipped with
state-of-the-art HPLCs, GCs, FTIR, Dissolution Apparatus and more.
We assure you the quickest turn around time in the industry for most
method development and validation projects.
Why coat tablets?
Aqueous based film coating can provide the following advantage over non-coated tablets:
We offer contract coating services for
large volume commercial products. Our state of the art coating
machine has been qualified for coating of tablets under cGMP
compliance. The Accela-Cota is equipped with a perforated pan
suitable for aqueous film coating and has a working capacity range of
60kg-310kg.
Color matching
Prior to starting the coating process for
sponsor's commercial products, we perform color matching activities
on the actual product that is to be coated for commercial use, in order to
ensure that color variation of commercially available product does
not occur when the tablets are coated from Allay. We usually request
a sample of uncoated tablets from the client for this purpose.
Types of tablets we can coat:
Technology transfer and scale-up
Process Optimization & Validation
Start-up of new manufacturing sites
On-site troubleshooting on formulations and manufacturing processes
Formulation development at client's site
high Potent or cytotoxic compounds
We offer assistance with
technology transfer and validation of new products & processes
into production, from the research stage. Our QA and production
experts can work hands-on at your site, acting as an extension of
your production team, to coordinate the scale-up batches of new
products & processes. This includes such tasks as:
We assist our clients with
troubleshooting and reformulation of problem-products, providing
technical expertise and support for production investigations.
We can provide support in the evaluation of new equipment and qualification
of alternate sources of raw materials.
At client's request, we can coordinate,
develop and prepare protocols for process / product validation
studies, including cleaning and equipment validation, prepare
validation reports, including data analysis, conclusions and
recommendations.
If required, we also coordinate the
execution of validation studies with production scheduling which may
include review and execution of protocols developed by other
individuals. We ensure proper training of production personnel in any
new process and/or equipment for successful new-product transfer to
production. For high potent and cytotoxic product development, we
provide on site assistance. Our experts can be on your site to
oversee formulation development and manufacturing activities at a
mutually agreed upon schedule.
