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Our regulatory and quality experts are an integral part of the team from the inception of your project. They provide essential guidance, based on thorough knowledge of the FDA's processes and key players. PharmaDirections’ specialty is preparation and review of small molecule non-clinical and CMC sections. Our regulatory experts have been involved in the preparation and submission of over 30 NDAs, over 100 INDs and 100’s of amendments, while our quality assurance managers can serve our client’s needs to have independent quality assurance support for their programs.
Key Benefits
Regulatory Affairs expertise available to every product development program
•Interpretation of FDA guidelines
•Oversight of manufacturing instructions, specification and process descriptions
•Preparation of documents for agency submission
•Regulatory Affairs expertise available to every product development program
•Control of amendments and FDA communications
Regulatory oversight and activities for external activities can be handled by our internal Regulatory Affairs staff
•Regulatory strategy development
•Pre-IND and pre-meeting briefing book preparation
•Amendment writing, control and submission
•FDA liaison for client
•CMC section of NDA preparation and review
Quality is built into all our product development and manufacturing projects
•PharmaDirections’ Quality Agreements ensure sponsors project meets all regulatory agency requirements for cGMP, cGLP and cGCP.
•Batch record review and release
•Failure investigations
•CAPA logs and actions
Documents, regulatory submissions and change control can be managed without the client’s need to invest in systems and infrastructure
•MasterControl™ for regulated and GMP documents easily assessed through the PharmaDirections’ portal
•On-line collaboration, routing and version control
•All regulated and GMP documents on-line and on-demand
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