Our services

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.

Pre-formulation Studies

  • 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.

Formulation Development

  • Solids (IR/ER/DR/Sublingual, Buccal)

  • Semi Solids (Topical and Transdermal)

  • Liquids (Solutions and Suspensions)

  • Transdermal (Patches)

Analytical Testing

  • 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.

Drug Delivery

  • Custom Technology Development

  • Platform or Individual Molecule Based

  • Sole Proprietary or Out-Licensed

  • All Major Dosage Forms

  • Risk Sharing Arrangements

  • Poorly Soluble Compounds Expertise

  • Immediate/Delayed/Extended Release

  • Sublingual and Buccal delivery platform

Contract Manufacturing (GMP & GLP)

  • Commercial volume manufacturing of solid-dose products

  • Single and Tri-Layer tablet compression capabilities

  • Batches to support Proof of Concept Studies

  • CTM Manufacturing for Phase I and Phase II NCEs

  • Pilot & Pivotal Batch Manufacturing of ANDAs (~100 kg scale)

  • Manual Packaging and Labeling of CTMs

Tablet Coating Services

Why coat tablets?

Aqueous based film coating can provide the following advantage over non-coated tablets:

  • Identification

  • Improve elegance

  • Stability

  • Mask color, odor and taste

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:

  • Prescription Drugs

  • OTC (Over The Counter) Drugs

  • Nutritional Supplements

Global Regulatory Services

  • IND,NDA, ANDA submissions

  • Foreign Facility and Product Registration

  • US Regulatory Agent Representation

  • Post approval Change Consultation

  • FDA meeting plans and meeting participation

Compliance Services

  • FDA 483, warning letters and consent decree resolution

  • Assistance with Site Inspection Readiness (including Pre-approval Inspections)

  • Training (curriculum is custom developed per clients choice)

  • Quality System Audits

Technical Consultation Services

  • 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:

  • batch record preparation

  • scheduling

  • raw material acquisition

  • supervising batch manufacture, etc.

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.