Your Most Complex Problems Solved
A Reliable Partner in Pharmaceutical Manufacturing and Development
Outsource to
a Dependable Team
Allay Pharmaceuticals, LLC. has been helping pharmaceutical companies worldwide, bringing products to market from concept to commercialization, assisting every step of the way.
We are your reliable outsourcing partner for quality and affordable product development, analytical services, regulatory and compliance support, as well as other technical services. Whether you need a stand-alone service or a combination of services, we can provide the solution that best fits your needs.
Experienced Specialists at Your Side
Our most valued asset is our proficient specialists, whose combined expertise encompasses all aspects of pharmaceutical development and operations. The experience profile of our scientists ranges from 15 to 35 years, with over 250 ANDA approvals and hundreds of successful formulations of NCEs developed and cGMP clinical trial materials manufactured.
Our regulatory and compliance support services include, but are not limited to, the filing of INDs, NDAs, ANDAs, resolution of FDA deficiencies, and site pre-approval inspection readiness. We serve a diverse group of clients globally as regulatory agents to assist with the registration of their facilities and their products with the US FDA and foreign health ministries. Our Technical Service Group provides on-site services to resolve manufacturing process issues and provide consultation for the qualification of equipment and laboratory instruments.
Our facility, registered with the Food and Drug Administration (FDA), is operated under current Good Manufacturing Practices (cGMPs) and an independent Quality Assurance program.
Our Assurance to You
We are confident that we can solve your most complex drug development needs within a relatively short period of time. We strive to deliver excellence in customer satisfaction. We hope to have the opportunity to provide the service that you need, with a target to achieve the desired outcome with maximum efficiency and accuracy.
Our Facilities
Miami, Florida
Allay Pharmaceuticals, LLC. conducts operations from its facility located in an industrially zoned business park in Miami, Florida. This facility functions as the corporate headquarters as well as the central hub for all technical operations. After recent expansions, the facility now consists of several independent units, with a total operating space of more than 16,000 square feet.
The manufacturing wing features six process rooms, each designed for specific process requirements with full isolation and containment. These suites are capable of supporting volumes anywhere between small-scale product development and commercial-scale manufacturing.
The analytical wing consists of three analytical laboratory suites, all equipped with state-of-the-art analytical instrumentation to support our clients' needs.
The facility features two spacious warehouse areas with incoming and outgoing material-handling processes and a secure controlled-substance holding area in compliance with DEA requirements. Elaborate operating procedures are enforced to run the facility in accordance with GMP guidelines.
Dhaka, Bangladesh
Allay has expanded its business internationally and has established a branch office in Bangladesh to develop long-term customer relations with its existing clients. The office is located in the capital city of Dhaka.
Mississauga, ON, Canada
This is one of our newer offices. More information will be coming soon.
Our Licenses and Compliance
About Our Pharmaceutical Manufacturing Team
Allay Pharmaceuticals LLC has been serving the industry since 2006. The company was founded by a group of highly competent professionals who are former employees of many of the top pharmaceutical companies in the United States. The experience profile of the multi-faceted management team includes:
Technical
- Analytical Development and Lab Testing
- Formulations and product development
- Manufacturing Processes
- Packaging
- Engineering
- Information Technology
- Administrative
Quality Control
- Quality Assurance
- Regulatory Affairs and Compliance
- NDA and ANDA submissions
- FDA, DEA, EPA, and OSHA regulations
- Entrepreneurial experience
- Business and financial operations
Our Vision
Through our diverse professional skills, clarity of purpose, and values, we aim to set a dynamic attitude to steer Allay to lead market trends in pharmaceutical services and to achieve sustainable growth for our company through client relations.
Establishing and monitoring customer requirements is the foundation for Allay's Quality Program and provides objective measures of Allay's performance. We will continue to work with and listen to our customers, with a focus on ensuring that their satisfaction remains a top corporate priority. Allay executives are responsible for creating and sustaining a clear and visible quality program, along with a supporting management system, to guide all activities of the company. We are dedicated to maintaining an environment that is conducive to full employee participation, continuous improvement, and personal and organizational growth.
Allay envisions establishing itself as a market leader in the pharmaceutical service business. One of Allay's top priorities is creating and preserving customer satisfaction. Customers are involved at every stage of the process in order to determine their needs and the key features to be integrated into our services.
We respect the needs and expectations of our internal and external customers, and we are committed to providing the product our customers demand with the service they expect from the people they can depend on.
An Expert Team at Your Side
The management team is complemented by highly skilled experts from all aspects of the pharmaceutical industry. When it comes to innovation and problem-solving, we are backed up by a number of highly sought-after scientists with proven track records in the industry.
Offering Career Opportunities
We believe that the training and development of team members in a culture of strict quality and compliance is critical to upholding Allay's brand image and serving the industry in general. Allay is constantly scouting for bright and talented individuals to join our team. Please contact us to inquire about available positions.
About Our
Wide Range of 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 clients' potential projects. If you would like to initiate a working relationship with Allay Pharmaceuticals, please submit a request for a non-disclosure agreement.
Pre-formulation Studies
We offer assistance with solubility studies, API stability, excipient interactions, and more. Prior to the development of any major dosage form, Allay's product development scientists perform critical experimentation to determine the physicochemical characteristics of the drug substance with the goal of designing optimum drug delivery systems. Basic pre-formulation studies include:
- Solubility determination
- pKa determination
- Partition coefficient
- 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.
OUR OTHER SERVICES
Formulation Development
Solids (IR/ER/DR/Sublingual, Buccal)
Semi-solids (topical and transdermal)
Liquids (Solutions and Suspensions)
Transdermal (Patches)
Drug Delivery
Custom technology development
Platform or Individual Molecule-Based
Sole Proprietary or Out-Licensed
All Major Dosage Forms
Risk-sharing arrangements
Poorly Soluble Compound Expertise
Immediate/Delayed/Extended Release
Sublingual and buccal delivery platforms
Contract Manufacturing
(GMP and 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 and pivotal batch manufacturing of ANDAs (~100 kg scale)
Manual Packaging and Labeling of CTMs
Global Regulatory Services
IND, NDA, and 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
Consent decree resolution
Assistance with site inspection readiness (including pre-approval inspections)
Training (the curriculum is custom-developed per the client's choice)
Quality System Audits
Analytical Testing
Complex Method Development
Method Validations and Transfers
Testing of Raw Materials and Finished Products
Stability, Storage, and Testing
comprehensive
analytical services
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 providing support. We assure you that the methods that we develop are robust, efficient, and cost-effective. Most of our proficient scientists come from contract pharmaceutical service backgrounds and have the experience to tackle the toughest method development challenges. Once methods are developed, we ensure they can be appropriately validated—in our laboratory or yours.
Our scientists are 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 is 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 of the quickest turnaround time in the industry for most method development and validation projects.
Tablet Coating Services
Why coat tablets? Aqueous-based film coating can provide the following advantages over non-coated tablets: identification, improved elegance, stability, and the ability to 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 the 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 60 kg–310 kg.
Color matching For Products
Prior to starting the coating process for the 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 products does not occur when the tablets are coated by our team. 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
Technical Consultation Services
We offer assistance with the technology transfer and validation of new products and 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 and processes. This includes such tasks as:
- Technology transfer and scale-up
- Process optimization and validation
- Start-up of new manufacturing sites
- On-site troubleshooting on formulations and manufacturing processes
- Formulation development at the client's site
- High-potent or cytotoxic compounds
- 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 the qualification of alternate sources of raw materials.
At the client's request, we can coordinate, develop, and prepare protocols for process and product validation studies, including cleaning and equipment validation, and 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 the 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-potential and cytotoxic product development, we provide on-site assistance. Our experts can be on your site to oversee formulation development and manufacturing activities on a mutually agreed-upon schedule.
