Bringing process engineering, project management, quality, and regulatory expertise to all we do
For over fifty years, BIOVECTRA has been dedicated to producing quality products and effectively managing client projects. However, as our clients’ needs have become more demanding, we’ve found new ways to partner to rise to the challenges.
Our teams work to stay ahead of evolving quality requirements and the leading global agencies’ regulatory demands. Specialized quality teams carefully align to support our products as they move through the development process and ultimately to the manufacturing floor.
Upon onboarding of your project, our process engineering group works hand-in-hand with the project team to proactively address any challenges around equipment and room set-up. Additionally, BIOVECTRA has long been dedicated to effective project management to improve our clients’ experience and keep programs on track. We continue to invest heavily in project management and technology tools, increasing efficiency and advancing speed-to-market initiatives.
Integrated Process
Engineering
Engineering
Thorough Analysis of Technical Aspects of Client Programs and Project Suitability
Careful and early analysis of project suitability identifies potential needs for equipment optimizations and facility fit. This upfront work reduces unwanted surprises as projects progress, significantly contributing to supply assurance.
Collaboration and Adaptability
Whether by collaborating within our organization to solve customer problems or collaborating directly with clients, we are dedicated to exceptional results. Our process engineering team paves the way as new requirements, approaches, and technologies are explored and implemented.
Dedicated Project Management
Empowered Project Management Team Improves Clients’ Experiences
We empower our project management team to lead projects throughout a product’s life cycle. Project managers review the process from all angles to map out a custom onboarding process, allowing us to be on time and schedule while producing high-quality products.
Broad Project Management Expertise
We benefit from a lot of cross-pollination within the organization. The net result is embedding quality and project management expertise in all that we do. A project manager is assigned as your primary point of contact for every project. They have diverse backgrounds and are established leaders with problem-solving mindsets.
Proactive Timeline Resource Management
We’re willing to add resources to meet tight timelines allowing clients to reach market delivery objectives.
Matured Quality System
Quality Dedication Improves Efficiencies
Our quality system includes all of the needed components such as training and traceability. This allows us to maximize on-time runs, achieve required product yields, ultimately resulting in the best possible cost of goods for our clients.
Quality Risk Management Approach
Thorough characterization of both products and processes facilitates highly effective decision-making by collaborating with our clients and among our internal team.
Specialized Quality Team Alignment
We continue to strengthen specialization areas among our quality teams and align those specializations to product life cycle stages, improving product quality and efficiency. BIOVECTRA takes a phase-appropriate approach to quality, and we continue expanding our expertise and capabilities to best serve our clients. As just one example, we see many requests for new types of impurity qualification and process characterization.
Demonstrated Regulatory Support
Established Relationships with Regulatory Agencies
We lay the proper foundation for your project’s regulatory needs by working closely with global regulatory agencies, especially FDA and Health Canada. Our strong performance with the regulatory agencies demonstrates our strict compliance with pharmaceutical processing standards and our commitment to deliver safe and effective products to our customers.
Strong Track Record of Successful Inspections
Our Quality Management System, operated across all sites based (on ICH Q7 and Q10), is monitored and regularly reviewed to ensure adherence to standards expected by our regulators, customers, and patients. This is reflected by our 15+ regulatory inspections with no critical observations.
Process Development
Demonstrated experience in process development and characterization, offering phase appropriate solutions and rapid optimization.
Analytical Development
Targeted analytical support from early development to validation of commercial processes and continuous process verification, all along the life cycle of your program.
Tech Transfer
Dedicated tech transfer teams ensuring a seamless transition from development to manufacturing - collaborating with our clients with a problem-solving mindset.
Clinical Development
Supplying our clients with pre-clinical and clinical material to enabling them to move quickly and cost-efficiently through the clinical phases.
Scale-Up
De-risking our client’s programs by effectively managing the transition from lab to pilot to manufacturing scale.
Commercial Scale
A proven history of commercial manufacturing partnerships growing alongside our clients. Effective collaboration increasing speed-to-market.
Ready to learn how BIOVECTRA can help?
Contact us today!
Contact us today!
