Integrated clinical development and supply: Breaking down the early-development journey of a small molecule.
The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.
It is not uncommon for small biotech and biopharma startup companies to overlook Quality & Compliance when formulating their drug development plans and budgets. However, industry guidance from the International Conference on Harmonization (ICH) recommends that serious consideration be given to Quality Assurance (QA) very early in the process.
The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.
The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.
NGT BioPharma Consultants Welcomes Daniel Schaufelberger, VP CMC and Specialist in Pediatric Drug Development.
NGT BioPharma Consultants Welcomes Michelle McGuinness, VP Regulatory Strategy & Submissions
As we continue to face business impacts of COVID, a new normal may be emerging in regulated industries, such as pharma and medical devices, when it comes to site visits and audits. As agencies like the FDA continue to rely on the virtual inspection, we need to take a look at the process, including review of documents and processes. How can these inspections be more hands-on and eyes-on, allowing for efficient and accurate outcomes? In this episode we bring a panel disucssion to help us better understand the intricacies of remote inspection featuring Dr. Ajaz Hussain, Dr. Alton Johnson, and Steve Thompson.
Our people are at the core of our business. We are featuring the amazing individuals who make NGT BioPharma Consultants a proficient and principled team to work with. Today we highlight Dr. Robert Dennehy, NGT’s Crystallization and Solid State Expert.
NGT BioPharma’s Dr. Robert Dennehy is appointed to Strategic Advisory Board at CatSci.
Our people are at the core of our business. We are featuring the amazing individuals who make NGT BioPharma Consultants a proficient and principled team to work with. Today we highlight Dr. Robert Dennehy, NGT’s Crystallization and Solid State Expert.
Our people are at the core of our business. We are featuring the amazing individuals who make NGT BioPharma Consultants a proficient and principled team to work with. Today we highlight Malcolm Berry, NGT’s API Continuous Processing expert.
