Regulatory Inspection Readiness Support for Your Business.
Getting your product to market is simplified with the support of a commercialization readiness experts that can provide expert advice, strategic direction and hands-on practical support.
Preparing to bring a product to market starts early in the product lifecycle with the development of a comprehensive regulatory strategy that not only provides a regulatory framework, but also considers other critical milestones and stage gates relating to manufacturing, analytical, supply chain and logistics topics.
Supply chain mapping.
Supply chain mapping is essential to understand how the physical product will enter the market, import requirements, licensing requirements, distribution networks and transport. The requirement for Manufacturing / Importation Authorizations (MIA), Wholesale Distribution Authorizations (WDA) and establishment licenses must be understood including a plan for gaining these licenses or onboarding partners.
Our supply chain experts understand that each supply chain is different and can use their deep understanding of local market requirements to provide an optimized supply chain map and strategic plans for implementation.
Good Distribution Practice (GDP).
Our Good Distribution Practice (GDP) experts can provide support with all areas of GDP compliance including GDP audits, provision of Responsible Persons (RP) / Responsible Persons for import (RPi in the UK) and Quality Assurance support for the development, implementation and management of Quality Management Systems to support GDP activities and licenses.
Early Access Programs (EAP).
Commercialization readiness is about getting medicinal products to patients and Early Access Programs (EAP) provide a means to supply patients with medicines that have benefited them on clinical programs or who need urgent access to a medicine and can’t wait for marketing authorization approval. Our cross functional experts in quality & compliance, regulatory affairs and pharmacovigilance can support with choosing the right EAP program, applying to the relevant regulatory authorities and supporting throughout this process.
Qualified Person (QP).
The role of the Qualified Person (QP) in commercialization readiness is key as they are responsible for disposition of the investigational medicinal product to the sponsor in clinical and EAP phases and then for disposition and certification of the medicinal product onto the market following Marketing Authorization approval.
In addition, the QP ensures compliance with GMP through oversight of the entire supply chain, provides QP audit and declaration for active substances and is a key resource for successful commercialization in the EU and UK.
Arriello can provide access to experienced QPs with a proven track record of commercialization support across all product types including ATMPS, CGTs, biologics, sterile parenteral and oral dose forms.
Successful commercialization is underpinned by the support of expert partners with deep knowledge of the market, global and local regulatory requirements and understanding of the unique needs of every commercialization program.
What our clients say about us.
Arriello has been truly committed to meeting our needs and providing us with guidance and recommendations along every step of way. We have now been using Arriello for approximately five years and are extremely satisfied with our choice.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
