Description
Adare Pharma Solutions’ deep experience can help streamline the application approval process of drugs. Adare's regulatory team has deep knowledge of various registration pathways and regulatory submissions across all phases of drug development.
Adare routinely prepares Drug Master Files (DMF) Module 3 content for Adare-manufactured products to support both US and ex-US drug product registrations. We have consistently demonstrated success in the preparation/approval of marketing authorizations of NDAs; ANDAs for the US and comparable filings required for non-US markets. We’re also experienced in developing responses to Health Authority information requests on Adare-manufactured products.
QA teams continuously revise QC documents as required to maintain cGMP compliance as well as participate in development support, contract manufacturing oversight, disposition of product, approving quality documents including SOPs, protocols, and methods.
Adare Pharma Solutions delivers products that meet the highest of quality standards. These standards are established through rigorous agreements and commitments with our customers, partners, and regulatory authorities. The cornerstone of our Quality Policy is executed through our Quality Management System.
Quality Processes Lead to Success
Quality Assurance
QA auditors partner with production
Deviation review and approval
Batch disposition
Quality Control
Raw material release
USP/NF and EU expertise
Release testing of intermediates and finished goods
Quality Systems
CAPA
Change Control
Internal Audits
Complaint management
Management review
Quality Agreements
Supplier Management
Global team to manage suppliers
Risk management tools define risk with materials and suppliers
Partnership with operations and procurement
Internal Partnerships
CAPA board
Change control board
Investigation board
Global collaboration
Leverage skills, knowledge, and expertise of our global quality network
Global Regulatory Affairs
Regulatory personnel in Vandalia (USA), Pessano (Italy), and Houdan (France) to support global Regulatory needs with consolidated experience in authoring of Module 2.3 and Module 3 for the US and EU
Internal and customer project development
Involved in project teams to define regulatory strategy
Authoring and review of Module 2.3 and Module 3 sections
Lifecycle management of Regulatory filings
Vandalia currently supports 4 ANDAs, 10+ DMFs, and 2 INDs
Authoring, review, and submission of sequences done in-house
SUPAC supplements for ANDAs
Pharmacovigilance activities
Drug Listings, Establishment Registrations, and State Licensing