Quality and Regulatory

micro hood 2 Diosynth Biotechnology has been producing Active Pharmaceutical Ingredients for over 75 years and prides itself on an unfailing commitment to quality, always with the goals of our customer in mind and knowing that a healthcare patient will be relying on what we manufacture.

Our Quality Assurance and Regulatory team is broadly experienced in the industry and has many years of combined knowledge applicable to a cGMP environment. Strong support is provided for:

Document development
Validation
Quality Systems
Product disposition
CMC and other regulatory services

Our staff is well versed in regulatory audit support and pre-approval inspection preparation and is ready to work with our customers to assure the highest probability of success for product registration.

Our Quality Systems undergo rigorous scrutiny by our customers. We work hard to meet project requirements by coordinating focused communication between our customer and internal support teams. We always keep that ultimate user, the patient, in mind as we meet the regulations and continuously review and improve our ability to provide safe, compliant, and high-quality biopharmaceutical products.

Our Quality Systems support early stage clinical trial materials from Phase I to Conformance Stage as well as commercial product. We truly understand the importance, and have demonstrated exemplary performance, safety, and quality in our operation.

Continuity in quality is assured by design for analytical method development and testing. Our analytical group combines the the expertise of development scientists with the GMP sophistication of the Quality Control analysts. Method development and transfer occurs internally within the quality group so there is a tremendous opportunity for interaction for communication between groups.

Our Quality team is always ready to host our customers and share our experiences and successes. We look forward to demonstrating how we can contribute to the success of our customers' programs.

See also