Successful compliance requires knowledge of the current regulatory environment, combined with an effective quality/risk management process. We can help. Full compliance with regulatory requirements is the cornerstone of successful product development. From high-level validation approaches to detailed on-site services, our professionals can help.
An effective validation master plan yields aligned expectations, improved budgeting, as well as better project management. We can help develop and promote employee behavior that aligns regulatory requirements with your business goals. Our experienced regulatory consultants can assist with early stage strategy discussions through IND submission.
An effective validation master plan yields aligned expectations, improved budgeting, as well as better project management. We can help develop and promote employee behavior that aligns regulatory requirements with your business goals. Our experienced regulatory consultants can assist with early stage strategy discussions through IND submission.
Services
Meridian BioGroup LLC, is a Maryland-based validation, regulatory, and compliance contract service provider to the biotechnology and pharmaceutical communities. Meridian brings qualified specialists from manufacturing, quality control, quality assurance, regulatory affairs, engineering, validation, and related backgrounds to meet its clients' needs in FDA-regulated environments.
We learn about your business, your project, and your methodologies to identify the right staff for the job-a staff with the technical skills, professional demeanor and attention to detail your project requires. Our talented personnel are committed to understanding your needs and delivering practical validation and compliance outcomes.
Ongoing quality assurance, validation and regulatory services for Catalent Maryland, first at Paragon's Johns Hopkins Bayview campus and now at the UMB BioPark, and both Harmans-BWI and Montgomery County manufacturing facilities; Manufacturing and facilities engineering support; GMP and GLP compliance.
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