Navigate your product through the Regulatory Approval Process.
Our regulatory consultants have many years of experience and expertise in regulatory strategy, dossier authoring, submission preparation and lifecycle management, across multiple product categories for prescription and non-prescription pharmaceuticals and biologics, medical device sand combination products. The Regulatory Team members skilled in clinical/non-clinical, chemistry manufacturing and control (CMC), risk management, and labelling.
These services can be integrated with expert Publishing and Quality Assurance solutions. We will navigate your product through the complete regulatory approval process with US Food and Drug Administration (FDA), Health Canada, European Medicine Agency and Japanese Pharmaceuticals and Medical Devices Agency (JPMDA). Offerings include, agency interface, pre-submission strategy, product classification, label development, common technical document (CTD) writing or review, support through to authorization post-market lifecycle management, advertising review, regulatory intelligence and training. Regulatory Services can be customized to fit your company’s needs.
Regulatory affairs expertise:
HPC regulatory affairs function provides guidance to customers regarding the chemical and biological molecules we help develop and manufacture, spanning the product lifecycle from development through clinical and commercial. Provides full support regarding regulatory affairs requirements and procedures, including:
Strategy:
Writing/Review/Filing of Applications:
Management:
Ensuring commercialization success:
Bringing a new therapy to market can be a long and complex process. Hayat Pharma Consulting have the local knowledge globally to help you along this journey. We offer global end-to-end commercialization services tailored to meet your needs. We provides solutions across the product lifecycle through unparalleled relationships and valued expertise. Our team ensure the success of your launch, maximize patient access and extend brand relevancy. We help existing manufacturers, as well as those new to various global markets, to develop and execute effective commercialization strategies, ensuring patients efficiently gain access to the latest advances in healthcare.
Submission strategy and support:
A well-developed submission is key to securing a positive listing recommendation and ensuring timely patient access. We help manufacturers demonstrate clinical and economic value to payers by communicating the value proposition of new products within the framework of the payer reimbursement review processes. In alignment with our clients, we develop messaging in submissions that clearly conveys the unique product characteristics that are important in the market access environment. Whether we manage the complete submission process, or tailor our support to incorporate administrative components for what you’ve already developed, we help ensure that you’re well-positioned for a successful product listing.
End-to-end solutions:
The journey to bring complex or innovative therapies to market requires a partner who is focused on the requirements for a strategic launch and operationalizing throughout the product lifecycle. We will guide you along the way and use our deep industry knowledge and network of connections to help you to plan and execute your commercialization strategy.
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