About RCA’s Strategic Consulting Services
Whether it’s a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your strategy is on time, and on budget — and you’re never embroiled in a costly mistake.
Follow the links below to learn more about our strategic consulting services in Pharmaceuticals and Medical Devices.
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To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
In this soundbite from RCA Radio, Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), provides examples of how different size companies leverage the stage of business they’re in to accelerate development with outsourced staff.
Start ups vs Large Companies
Using Staff augmentation to bring in SMEs gives companies the ability to scale up and scale down quickly without taking away people from other projects.
Start-ups are typically not ready to bring on a full-time employee. In cases like these, we can bring in a subject matter expert (SME) that can help work through any regulatory, compliance, or quality problem and assist on an as-needed base.
Larger companies typically need help when they are performing a project such as adding a new manufacturing line into a facility. They don’t do this all of the time and only need the extra resources for this particular project. In cases like these, we will put together a team with the right skillsets that can complete the particular project. Once completed, RCA perform a hand-off with the client, and our team steps away from the project.
Listen to the full episode “Outsourcing and Staff Augmentation” now!
All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA has consultants that develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.
Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. These companies turn to outsourcing to manage operations and tactical skills, and also help adopt best practices.
Successful execution comes through project monitoring, issue resolution, and risk management of the process through clear leadership. RCA’s team of experienced project management professionals organize and manage resources to ensure that projects are completed successfully, on time, and within budget.
RCA Outsourcing Services
Project Management
To be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently.
Our outsourced staff capabilities for project management capabilities include:
- On-site Project Leadership or Project Management Support
- Design and Implementation of a Project Management Office
- FDA Workshops
- Project Assessment, Remediation, and Follow-up
- Advanced Schedule Optimization and Management
- Development and Implementation of Compliant Methods
- Risk Management
- Issues Resolution and Decision Tracking
- Change Management
- Performance Measurement and Tracking
- Tool Selection for Program Portfolio and Resource Management
Staff Augmentation
Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add experienced professionals to your staff for a short- or long-term project through our medical device staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:
- Quality Assurance
- Regulatory Affairs
- Validation
- Operations
- Product Development
Consulting Support
Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.
Advantages of Outsourcing
When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. RCA’s quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution, and implement that solution for the utmost success in your project’s completion.
Our goal is to help you get your projects to completion on time and on budget — all while outsourced staff keeps superior quality at the forefront of your every task. And with a team of more than 500 pharmaceutical consultants and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.
Strategic Outsourcing
Medical device manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for outsourced staff and strategic outsourcing services.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
One of the most crucial parts of running a business in the pharmaceutical or medical device industry is meeting the standards that will ensure your customers receive the highest-quality service. That’s why many businesses today choose to outsource certain functions of their post market surveillance activities.
Let us help you Outsource your Post Market Surveillance Activities. Contact Us Now →
Outsourcing is a business strategy that only began to surface in the 1980s and 1990s. Since then, it has become a powerful value proposition for industries everywhere. In the 2000s, businesses within the life sciences industry started implementing the practice. Now, the outsourcing of external resources for compliance needs is a common strategy for companies looking to expand their reach and climb the industry ladder.
Why Are Certain Functions Targeted for Outsourcing?
Companies may choose to outsource any number of activities to improve business operations, but there are a few specific types of functions that leaders tend to target for outsourcing. For example, companies often outsource lower risk activities that include higher volume but lower-complexity tasks.
The reason for this is that there are many expert consultants needed for complicated specialties that businesses are responsible for. However, when leadership removes the tedious or time-consuming tasks, such as data management, they may increase the team’s ability to focus on the larger picture or invest in business ventures.
Outsourcing low-risk tasks lifts a significant burden from the shoulders of leaders and employees while allowing them to focus on the creative, strategic and higher-risk parts of the business instead.
Why Outsource Post Market Surveillance Needs?
The reason so many businesses choose to outsource rather than use internal resources is the challenge of the recruiting process. Companies often find that understanding regulations, compliance, hearing the Voice of the Customer and managing regulators is an important core competency / knowledge that balances other internal functions and decision making. Thanks to ever-changing standards and laws in the medical device and pharmaceutical industries, very few companies have the in-house resources to keep these standards up-to-date.
Managing post market surveillance activities may be outside the realm of your team’s skill set and understanding, but outsourcing allows you to work with experts in the field. While compliance issues can hold your company back, having an experienced partner at your side ensures that all of your compliance needs will be in order.
Some of the long-term benefits of outsourcing post market surveillance activities include:
- High-efficiency value proposition: With the help of an healthcare consulting firm, you can more quickly and effectively serve your customers. Over a long-term basis, this will help you both retain customers and attract new ones.
- Lower functional costs: Reducing operational costs so you can increase profits and grow as a business is one of your main goals. Thanks to the benefit of a more efficient work environment, you will save capital for opportunities like mergers and acquisitions.
- Refocus talent and skill: Free up your high cost internal resources to allow them to focus on critical work and decisions which you can then leverage for the benefit of your business by outsourcing low-risk tasks. Refocus your most valuable members and resources on their greatest strengths while leaving the rest to external experts.
Outsourcing your post market surveillance activities is an area that continues to grow worldwide. With the help of a third party, you can keep everyone in your business assigned to the tasks that allow them to best use their core competencies and create a more productive work environment.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
Cell and Gene Therapies also known as (ETMPs) have continued to evolve in recent years. Over the last 15 years the industry and regulatory bodies have continued to learn more about them and in recent year there have been more and more guidance documents released outlining what the regulating bodies want the manufacturers and developers of these different biologic products to look for and adhere to during development.
Cell and Gene Therapies are Personalized medicine meaning, one patient, one drug. These types of drugs are not produced in large scale or in batches like the standard biologics or drugs we have been used to manufacturing up to this point. They are made in very small batches that are produced in laboratory setting but require the same environmental controls as your typical aseptic processing but a much smaller scale.
Listen to the full episode “Pharmaceutical Industry Outlook” now!
Issues with Approval
The issues companies face when manufacturing cell and gene is that they are introducing variability right away in the process in terms of the active ingredient. In this type of manufacturing, the active ingredient is the specific patient’s genome. With the variable ingredient, manufacturers do not know what they are working with upfront which makes the process difficult. It is a non-tradition way of thinking that makes validating a process that has that kind of variability hard on cell and gene companies without experience in this area.
The Non-traditional Approach
This approach to drug approval is based on an individualized patient’s genetic makeup and requires the developers to make a constant process of taking the patient’s genetic material and producing the cell and gene therapy dose at the end. Developers have to be able to categorize the variable, walk it through the process, and then categorize it again at the end making sure it is safe and effective for the patient even though it is based on their cell and gene genetic material.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
During times of crisis — such as the global pandemic — keeping supply chains moving becomes even more important. Issues with supply chains can lead to critical shortages of items like medications, which people need to remain healthy and combat the situation at hand. Unfortunately, the COVID-19 outbreak has caused early disruptions to the pharmaceutical supply chain as companies adjust their policies.
The long-term health of manufacturing will depend on the adoption of new approaches and care in pursuing solutions that may be impacted by future legislation or restrictions related to each industry. Here are some ways your company can do its part in maintaining the pharmaceutical supply chain during and after the coronavirus outbreak.
Having trouble with your Supply Chains? Contact RCA Now →
Open up Lines of Communication
Communication at all levels between clients and suppliers becomes essential during difficult times. Transparency and early warnings on both sides can help you avoid instances of confusion and blame. When you’re on the same page, even if you do not hear the answers you want to hear, you can figure out how to deal with the situation productively. Be up front about delays or issues you run into along the way so that your clients understand the situation.
Review Your Quality Risk Management Plan
The global pandemic has required many changes to the way we work. For instance, you may be dealing with issues such as delayed supplies on your end, with overseas shipments arriving long after they’re expected. You’ll need to review your quality risk management plan to account for such unexpected dilemmas.
Conduct a thorough analysis of all the ways your own pharmaceutical supply chain may be impacted. For instance, other countries may have tightened their export requirements, which will make it harder to access the material you need. Countries may have increased security, which means more detailed inspections of exports and potentially longer delays. Consider other ways materials might be affected as they travel to your plant too, and make proactive changes to address these issues.
Adjust Production Schedules
The production schedule you used before the COVID-19 pandemic may no longer make sense. You’ll need to adjust your schedules based on when you receive the materials you need and any new timelines instituted with your clients due to the outbreak. Make it clear to your workers why you are initiating the changes. You need buy-in from top to bottom on changes to ensure as few hiccups in the transition as possible.
Monitor Your Supplies
Everything is moving more slowly right now, including the movement of supplies. The quicker you can adjust to these changes, the less they will interrupt your production process. Know where your supplies are and track their arrival while anticipating any possible disruptions. Some facilities abroad are not ready to return to production. Other countries have shut down borders. Educate yourself on the circumstances that could impact your supplies.
Foresight and planning ahead can help you focus on the things you can control during this new and sometimes challenging time. Continuing your incorporation of crucial resources into the market is critical. If you need assistance with ways to maintain your supply chain, contact Regulatory Compliance Associates® Inc. for more information.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].