GxP compliance guidelines and compliance are a vital component in operation, especially within the pharmaceutical industry, but many in the industry are not sure what it means or how to ensure compliance with these regulations. First established in the U.S by the Food and Drug Administration (FDA), the 'x' in GxP stands for a particular field, such as distribution (GDP), manufacturing (GMP), laboratory (GLP, and so on. The of GxP, especially within the pharmaceutical industry, is to ensure that manufactured products are fit for use and safe. However, ensuring that your particular enterprise is compliant with the GxP regulations is easier said than done. That is where we come in.
Flatworld Solutions (FWS) is a leading provider of GxP services to clients from across the world. We help with pharma GxP compliance consulting to help our clients mitigate and compliance risks. We help our clients to manage remediations and ensure that their patients keep receiving the products and treatment that they need. Our pharma GxP compliance services include strategic advisory, auditing, data integrity services, inspection support, and technical writing services, among others.
GxP Compliance Services We Offer
We are a leading GxP service provider and can provide you with services that keep the supply chain flowing. If you are looking to maintain GxP compliance in the pharmaceutical industry, you won't find a better partner than us.
Our services include -
We can help with general GxP audits and other inspections even from a remote location. With our effectiveness checks and verification audits, we can help you ensure that you have good distribution practices and quality systems.
As a leading GxP compliance company, we provide a range of compliance advisory services, including helping with regulatory submissions, communications, and preparing your team for health authority meetings.
Inspection Support Services
Our professional GxP experts provide support for hosting, readiness assessments, conformance reviews, and backroom activity. We will review your site presentations, hosting processes, and tour routes.
Data Integrity Services
With our data integrity services, you get access to professional audits and analyses, procedure development help, staff interview support, fraud evaluation, and subject matter training, among others.
Technical Writing Services
We have a team of professional writers that can assist you to create validation protocols and reports, SOPs, audit responses, FDA correspondence, and other technical reports.
GxP Compliance Process We Follow
Flatworld follows the standards of the industry to ensure that the client receives the best services. We keep with the deadlines and commit to the services however challenging it may seem. Our process is as follows -
01. Manage Risk
We assess the severity of the challenge and prepare documentation, and control the risk of product failure
02. Prepare Documentation
If you have a standard operating procedure, we routinely publish the same and conduct reviews on the document periodically
03. Control the Process
If your product is yet to meet the specific industry standards, we ensure the compliances are met
04. Record Progress
We record the timestamped proof that the said task is performed as per the protocol
Other Services You Can Benefit From
Why Outsource GxP Compliance Services to Flatworld Solutions?
Flatworld Solutions is a leading GxP compliance service providing company and provides you with many reasons to work with us, including -
We provide our expert services at highly affordable rates, ensuring you get the most bang from your money.
We are fully compliant with industry regulations, such as the HIPAA other laws operating in various countries around the world.
Tools and Technologies
All our GxP experts use the latest workflows gained from substantial experience in the field as well as leading tools and frameworks to provide high-quality services that make a difference to your enterprise.
Our ISO 9001:2015 certification and extensive experience ensure that you will always receive services that go beyond what is agreed upon and expected. You will always receive the most comprehensive services when you outsource to us.
All our services are provided by seasoned veterans who work out of world-class offices equipped with all the required tools and infrastructure facilities.
Quick Turnaround Time
We are stringent about working efficiently to ensure that every deadline is met, many times well in advance.
Our team is comprised of veterans from the industry with the first-hand experience in how to ensure GxP compliance.
Client Success Stories
FWS Provided Effective and Efficient Patient Onboarding Solutions to a US-based Healthcare Provider
A leading US-based healthcare provider was looking for professional patient onboarding services. We provided the client with exceptional services quickly.
FWS Provided Timely and Accurate Teleradiology Solutions to an American Medical Imaging Firm
A leading medical imaging provider based in the U.S. required a professional firm to reduce its teleradiology backlog. We provided high-quality services quickly and completely reduced the backlog to zero.
Outsource GxP Compliance Services to Flatworld Solutions
I am highly impressed by your hard work and superb quality of service! You also charge very reasonable prices. Thank you a million times!!Assist. VP, Medical Company, VA More Testimonials »
Flatworld Solutions is a leading provider of GxP services to a global and diverse clientele. With our significant experience and expertise, as well as our numerous certifications and accolades, you can be sure that you will receive the most competent, reliable, and professional services when you outsource GxP compliance services to us. We also work diligently and efficiently to provide services that are priced very cost-effectively.
If you are looking for accurate and affordable services, get in touch with us today!
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