Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®
The COVID pandemic of 2020-21 has impacted the Life Science companies in myriad ways. The greatest impact has been on companies to develop ways to continue to produce their life-saving products, not just COVID related products, with all of the restrictions, supply disruptions, and other pandemic factors. The onset of the pandemic brought the need to rapidly develop, manufacture, and distribute large amounts of diagnostic devices, vaccines, and other therapeutics for COVID. The FDA and other regulatory Agencies have responded using their Emergency Use Authorization (EUA) and other authorities to make resources available to combat the pandemic and keep people healthy.
In the pandemic aera, speed saves lives. For example, a typical vaccine development and manufacture process including the R&D phase, Pre-clinical trials, Phase I, II, and III trials, FDA review and approval, commercial manufacturing and distribution takes about 73 months to completion. The COVID diagnostics and vaccines were built on technology that was already developed and the specific vaccines and diagnostics were developed and scaled to produce hundreds of millions of doses in less than a year.
The US government initiated Operation Warp Speed (OWS) to accelerate the vaccine distribution and administration process. OWS supports private industry with overall coordination of the pandemic response effort, logistical support, personnel support, and resources to assure that every one of the almost 370 million American who wants a COVID vaccine, needs a COVID test, or needs treatment for COVID infection gets what they need as fast as possible. The current vaccines require two doses, so industry has to make and distribute and the health care system needs to administer almost 800 million doses of vaccine.
All of this is easy to do on a small scale, but when you have to do it 800 million times, that’s where the challenges arise.
Throughout the pandemic, we at PSC Biotech® have been offering our expertise and providing variety of solutions to help companies continue to execute their mission, be it COVID vaccines, diagnostics, or therapeutics or just being able to continue to supply your life saving products to your customers. PSC Biotech® provides professional services solutions that include:
- Computer Systems Validation (CSV): Electronic Document Management Systems, Data Integrity, Laboratory Equipment Software Validation
- Quality Assurance and Compliance support: QA Reviews (GLP, GMP, GCP), 483/ Warning Letter Remediation, Risk Assessments, Microbiology Laboratory consulting
- Technical Writing: FDA Responses, SOPs, documents, Forms, Protocols
- Regulatory Affairs: NDA/BLA/ANDA/INDA/510(k)/PMA submissions, Pre-approval and post- approval support, Regulatory agency Interaction consulting
- Commissioning, Decommissioning, Qualification and Validation (CQV)
- Calibration: Equipment Rentals, Validation, Instrument Calibration, Process and Quality IT support, SQE support
- Audits: Supplier, Laboratory, Facility, PAI preparation, Gap Analysis
- Project Management
- Engineering support: Facility Optimization, Equipment Selection, Process Design and P&ID
PSC Biotech® also offers a fully validated, integrated, electronic Quality Management System (eQMS) software solutions called ACE® (Adaptive Compliance Engine®), the turn-key eQMS solution, ACE Essentials™, and AuditUtopia®, the world’s easiest to use audit hosting and management software to help your company not just to survive COVID, but to prosper in these challenging times.
Contact us if you need support with any of these services to help you accelerate your success!