GMP QA Support is important at all stages of the drug product development life cycle to ensure medicinal products are consistently developed, produced, and controlled to relevant regulatory and quality standards. The appropriate level of GMP QA Support within an organization ensures that any pharmaceutical production risks which cannot be eliminated through the testing of final drug substance or product are acceptably minimized for patient safety.
Our Approach
Understanding the different international regulations, guidelines, and guidance documents is key to being able to offer the correct level of GMP QA Support to clients. RegDev consultants quickly determine the level of support needed and where it is needed, whether it is in the areas of Inspection Readiness, Quality Management System, Remediation, Regulatory Intelligence, or Training
We engage extensively with our clients to gain a full understanding of the phase in which the client’s products are in (i.e., development, clinical or commercial), the category of the products, the global regions within which the products will be submitted as an Investigational New Drug (IND) or Investigational Medicinal Product (IMP), or where the product/s are or will be marketed as approved products. RegDev believes that this initial approach is essential to achieving the highest level of GMP QA Support success for its clients.
DEEP CLIENT ENGAGEMENT
RAPID PHASE IDENTIFICATION
GLOBAL SUPPORT
CLEAR PROJECT PLANS
REGULATIONS AND GUIDELINES GUIDANCE
VENDOR MANAGEMENT
THE DRUG DEVELOPMENT LIFECYCLE
As activities progress through a product’s development life cycle (i.e., early phase to late phase/clinical and late phase/clinical to commercial), associated expectations differ, becoming more stringent as the development cycle reaches the commercial phase. Keeping abreast of new or updated international regulations, guidelines and guidance documents is another area of GMP QA Support in which RegDev, Inc. ensures that its clients remain current throughout all phases of the drug product development life cycle for their products.
QUICK IDENTIFICATION, RAPID RESOLUTION
Whether due to resource constraints or a lack of GMP QA Support expertise, our clients immediately benefit from knowing that RegDev has a successful record of supporting global clients with their specific GMP QA Support needs. One of RegDev’s proven strengths is our speed and efficacy in determining the level of GMP QA Support needed and where exactly it is needed. This is of paramount importance to the success of any client project and our clients benefit significantly from improved performance levels within these GMP QA Support areas.
GLOBAL SUPPORT
When referring to GMP QA Support within the pharmaceutical life sciences industry, some words or descriptors are sometimes used interchangeably, especially when they are being referred to within different global regions. Clients of RegDev understand that no matter where their business activities are focused globally, RegDev will discern all GMP QA Support terms and definitions and, together with its clients, focus on the products, premises, people, processes, and procedures within scope, whether internally or with external business partners.
Team Member Insight
“As a veteran member of the RegDev team, which includes professionals with very broad and varied experience from both industry and regulatory agency backgrounds, I feel privileged to be able to share this experience with our clients. There is nothing more satisfying than assisting our clients
with mentoring their employees and helping them achieve and maintain compliance at every step of the companies’ product development journey!”
