Medical Compliance & Pharmaceutical Compliance Consulting

Total Solution Services is your trusted compliance company and partner for comprehensive medical device and pharmaceutical compliance. We specialize in providing end-to-end validation, regulatory, and quality assurance services that help you navigate the complex landscape of medical and pharmaceutical standards. Our dedicated team has a deep understanding of industry regulations, including FDA requirements and GxP guidelines, and is committed to delivering solutions that prioritize safety, efficacy, and compliance.

Additionally, whether you’re developing a new medical device, conducting clinical trials, or ensuring regulatory compliance for a pharmaceutical product, we’re here to support your business’s success at every step. Total Solution Services combines local insight with global expertise, making us a preferred choice for medical and pharmaceutical industries.

Why Us for Medical Device and Pharmaceutical Compliance?

We’re proud to serve businesses in our community while bringing the knowledge and expertise necessary for navigating global regulations. Our approach is rooted in understanding the unique needs of each client, allowing us to provide tailored, effective solutions for companies of all sizes. With over 50 years of combined experience, we offer the insight, resources, and dedication that our clients expect from a trusted compliance partner.

And when you work with Total Solution Services, you’ll benefit from our commitment to quality, responsiveness, and integrity. Our team’s industry knowledge and dedication to client satisfaction set us apart as a leading provider of validation and compliance services for medical devices and pharmaceuticals.

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Our Key
Services

We offer a comprehensive suite of services designed to address all aspects of medical device and pharmaceutical compliance. Here’s an overview of our core services:

Medical Device Validation

Medical device validation is a critical step in ensuring that your product performs as intended and meets all necessary regulatory requirements. Our medical device validation services cover every stage of the validation process, from initial design through final testing and documentation. By validating your device, we help you avoid potential compliance issues, reduce the risk of recalls, and bring a safe, effective product to market.

Our validation process includes rigorous testing and documentation in accordance with FDA standards and ISO requirements, ensuring that your device meets regulatory standards for performance and safety. Whether you’re developing a new device or updating an existing one, our team provides the validation expertise you need to achieve compliance and market success.

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Pharmaceutical Validation Services

In the pharmaceutical industry, validation is essential for ensuring product quality and regulatory compliance. Our Pharmaceutical Validation Services help your organization validate manufacturing processes, equipment, and computer systems to meet industry standards. We offer support across multiple stages, including process validation, equipment validation, and software validation, to ensure that every element of your production chain is compliant and consistent.

Additionally, our approach is comprehensive, covering installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to ensure a seamless validation process that meets both FDA and international standards. With Total Solution Services, you can confidently produce high-quality pharmaceutical products that adhere to the strictest safety standards.

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Clinical Trial Support

Navigating clinical trials requires careful planning, management, and documentation to meet regulatory requirements and ensure accurate, reliable results. Our Clinical Trial Support services are designed to provide the expertise you need to streamline trial processes, maintain compliance, and protect the integrity of your data. We work closely with your team to develop protocols, monitor trials, and manage data collection and reporting in alignment with FDA and international guidelines.

So whether you’re conducting clinical trials in or coordinating multi-site studies, our team offers local support with global expertise to help you achieve successful, compliant trial outcomes.

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Regulatory Affairs

Regulatory compliance is a fundamental aspect of bringing a medical device or pharmaceutical product to market. Our Regulatory Affairs services provide expert guidance to ensure that your products meet all applicable regulatory standards. We assist with preparing and submitting documentation, managing communications with regulatory bodies, and maintaining compliance throughout the product lifecycle.

Our team’s extensive knowledge of FDA, EMA, and other global regulatory agencies also allows us to support your organization in meeting the regulatory requirements of multiple markets. From initial registration to post-market monitoring, we’re here to provide the support you need for smooth regulatory processes.

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Quality Assurance and Quality Control

Quality assurance and control are essential for maintaining the safety and efficacy of medical devices and pharmaceuticals. Our Quality Assurance (QA) and Quality Control (QC) services focus on creating robust systems and protocols that ensure consistent quality across all stages of production. We assist with establishing quality management systems (QMS), conducting audits, and implementing corrective and preventive actions (CAPA) to prevent issues before they arise.

By prioritizing quality at every step, we help you build a strong foundation for regulatory compliance and market success. Our QA and QC services are tailored to meet the unique needs of your business, supporting continuous improvement and operational excellence.

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contact Total Solution Services today

Are you ready to take the next step in compliance for your medical device or pharmaceutical product? Well don’t wait any longer: just contact Total Solution Services today to schedule a consultation or visit our website to learn more about our comprehensive validation and compliance services. Let us help you achieve regulatory excellence and bring safe, high-quality products to market.

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FAQs about Our Medical Device
and Pharmaceutical Services

QA and QC ensure that products meet stringent safety and quality standards, preventing issues that could impact patient safety or regulatory compliance. We work with you to develop systems that maintain high standards across all areas of production, ensuring product consistency and reliability.

1. What is the purpose of medical device validation?

Medical device validation ensures that a device consistently performs as intended, meeting both safety and regulatory requirements. Validation is essential for avoiding compliance issues, reducing risks, and ensuring patient safety. Our team provides thorough validation services to help you bring safe, compliant devices to market.

2. How does pharmaceutical validation support regulatory compliance?

Pharmaceutical validation confirms that every aspect of the production process is reliable and consistent. By validating equipment, processes, and computer systems, we help you maintain regulatory compliance, reduce production errors, and ensure product quality.

3. What role does regulatory affairs play in bringing a product to market?

Regulatory affairs involve ensuring that your products meet all regulatory requirements before entering the market. Our team assists with documentation, communication with regulatory bodies, and ongoing compliance to streamline the regulatory process and reduce time to market.

4. What are the benefits of clinical trial support services?

Clinical trial support services ensure that trials are conducted in compliance with regulatory standards, protecting data integrity and ensuring accurate results. We help you design protocols, manage data collection, and maintain compliance, which supports successful trial outcomes and faster regulatory approval.

5. Why are quality assurance and quality control important?

QA and QC ensure that products meet stringent safety and quality standards, preventing issues that could impact patient safety or regulatory compliance. We work with you to develop systems that maintain high standards across all areas of production, ensuring product consistency and reliability.