Proven Global Track Record In Quality & Regulatory Services
With numerous product launches across the globe, we are uniquely positioned to guide our customers through the intricate and often complicated regulatory processes unique to the various regulatory bodies in countries throughout the world. Experience is key in anticipating and interpreting the best approaches to regulatory approvals, and Adare Pharma Solutions’ deep experience can help streamline the application approval process.
We collaborate with our development partners to support an efficient and robust registration process—both US and non-US—throughout the product development process. Our regulatory team boasts a second-to-none in-depth 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
Adare’s Lean Six Sigma training program has been accredited by The Council for Six Sigma Certification, an official industry standard of Six Sigma accreditation for training providers worldwide. This ensures that all individuals who have completed Adare’s training program have learned the complete Six Sigma body of knowledge and met a required standard of proficiency for Six Sigma and its implementation.
We provide products that meet the highest quality standards by establishing agreements and meeting commitments with our customers, partners, and regulatory authorities.
