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Biopharmaceutical and Biotechnology
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WE PROVIDE
Business Operations, Due Diligence, Auditing, Quality Services, Regulatory Affairs, and Technology Transfer Support.
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WE OFFER
Phase-appropriate Quality and Regulatory solutions to minimize on cost without sacrificing quality.
Quality Systems
We can draft SOPs, create a brand new Quality Program, and everything in between. Some of the services "in between" are: Interpreting regulatory requirements, implementing an eQMS, performing Risk Assessments, conducting Investigations (with advanced root cause analysis), establishing Quality Metrics, implementing Environmental Monitoring (EM) programs, executing internal audits and other site inspection-readiness activities, developing and qualifying Analytical Methods & Specifications, as well as Reviewing & Implementing Change Management Controls & individual projects.
Regulatory Affairs
This is one of our biggest areas of focus. We continue to help our clients with Document Preparation, Technical Writing, and Reviewing for FDA and Global Filings. We work through NDAs, INDs, ANDAs, and NADAs. We have provided assistance on Regulatory Filings & Strategies for years. We provide a variety of services related to CMC, including: CMC Development & Gap Analysis, Supplier & CDMO Management, and Technical Writing for Module 3. We are ready to help with any Regulatory Compliance issue.
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Technical Support
Our Technical Support services are broken up into three divisions: Validation Engineering, Scientific Assistance, and Technical Services. We have worked with antibody drug conjugates (ADC), monoclonal antibodies (mAb) nucleic acids, proteins, peptides, lipid nanoparticles (LNP), liposomes, lipoplexes, parenteral drug products, and polymeric nanoparticles (PNP). Consultant experience executing: Equipment Validation, Process Validation, eQMS Implementation and Validation, CSV (21 CFR Part 11 Compliant), Technology Transfers, Process Simulations, Engineering Batch Oversight, Media Fill Qualifications, Environmental Monitoring Program Implementation and Validation, Program/System Assessment, Develop & Optimize Laboratory Controls & Analytical Methods, Investigations, Process Optimization, and Process Evaluation & Design.
Drug Delivery Systems (DDS)
Over the past decade, we have been at the forefront of advanced drug delivery system commercialization. We have worked with all of the major vendors, CDMOs, and innovators related to LNPs & other lipid-based nanocarriers. We have the experience of taking a Pre-Clinical drug product to market. We work to develop non-GMP and cGMP Processes to deliver mRNA, DNA, and other APIs to targeted sites and tissues. We have the ability to develop your Analytical Methods, establish your Stability Program, and manage your Clinical and Commercial Supply Chain. With over 50 LNP Technology Transfers completed to date, we are happy to help you at any point in the product lifecycle. We were experts in the space before Covid made mRNA and LNPs household names; our experience is, legitimately, second to none.
Operations and
Manufacturing
We have the Manufacturing and Product Development expertise to get your drug to market in the most expeditious way possible. We rely on our network of CDMOs, CROs, and Supply Chain Management staff to oversee your Clinical Supply. Current projects also include: Project Management, Supply Chain & Procurement, Business Process Management, and Sales & Marketing. We are ready to start by planning the execution of your next Technology Transfer or take a look at your current processes with a fresh perspective and LEAN approach.
Auditing
A second pair of eyes to review and evaluate your systems and processes is always a good idea. We can provide this service in-person or virtually. Since the pandemic, we have increased our offerings of virtual audits and documentation reviews. Now that there are vaccines and effective protocols, we have hit the road again and are ready to evaluate your Supply Chain. We can get you fit by performing Facility Inspections for cGMP-readiness, Due Diligence, and Gap Assessments. Our experience focuses on getting manufacturing facilities ready for FDA and EMA inspections for Excipient, drug substance (DS), and drug product (DP) Commercial launches, as well as Post Approval Changes (PACs).
Training
We provide Training that is customized to your company's specific needs. We can tailor any of our programs to use data, historical trends, and examples from your company, as well as others in the industry, to provide a tremendous value to your team. We can create and provide Training, Curriculums, and Procedures in the following areas: Investigations, Root Cause Analysis, & CAPAs, Change Management, Supply Chain Management, Project Management, Technology Transfers, Aseptic Technic, cGMP & FDA Guidance, Quality Control, and G&A.
Facilities Design
By utilizing the talent of Industry Leading Experts, Specialized Contractors, and our Partners & Sister Companies, we are able to build you the Laboratory, Manufacturing, and Administrative spaces required to operate most effectively. This includes developing and enhancing existing drawings for HVAC, water, and sterilization systems. Current projects include: developing flows of materials, equipment, & personnel, Designing facility per client requirements, establishing laboratory operations, and performing audits during construction & installation.
