GxP compliance services in pharmacy helps to ensure pharmacy companies meet industry regulations and come up with products that are safe and exactly meet all quality standards throughout the production process i.e. from document creation for risk-based C&Q, validation of manufacturing, and cleaning processes to routine production. However, the challenge lies in interpreting it correctly and putting it to practice.
Outsource2india has over 2 decades of experience in providing pharma companies with high standards of GxP services. We have a team of experts who have in-depth knowledge in pharma-related GxP and experience in assisting several pharma companies to implement and follow the right GxP standards.
As a specialized GxP Compliance company, We offer a range of GxP services to pharmaceutical companies around the world. Some of these exclusive services include -
We specialize in comprehensive advisory services for pharma companies. This includes proving gap analysis views to industry veterans looking for feedback. Some of our exclusive GxP Compliance Consulting services include -
Our audit services are driven by wide knowledge, experience, and understanding of the drug manufacturing process. Our GxP service audits to come with the following features -
Our services also entail providing subject matter training, fraud investigations, and internal evaluation. Each of these processes is documented to assist your legal counsel take up matters whenever issues arise. To ensure data integrity accuracy we assist you with -
To assist you to stay compliant and improve continuously we partner with businesses such as clinical studies, pharmaceutical producers, medical device developers, and laboratory service providers to assist them to align with new and changing regulations that keep evolving throughout the lifecycle of the drug product and device development. We assist our clients to meet GxP Compliance requirements in the following ways -
Documentation is an important aspect of ensuring GxP compliance. As per governing body requirements, all pharmaceutical companies must have in place and maintain procedures for documents management for ensuring a quality system in place. Our documentation specialists have vast expertise in assisting pharmaceutical companies to develop validation protocols, SOPs, reports, annual product reviews, audit responses, FDA correspondence, and other technical reports.
There are several advantages of engaging an offshore consulting firm to carry out a comprehensive GxP compliance services audit program. Some of these include -
Outsourcing GxP compliance services audit help you save a lot on costs. The costs involved in hiring experienced and domain-based auditors are always very high.
By hiring third-party GxP service providers you can bring down the number of full-time staff needed to carry out an audit function without compromising on the objective of the audit.
Outsourcing helps you get easy access to a large pool of experienced auditors with considerable exposure to industry requirements.
Drug companies have limited resources in this area which is duly filled in by third-party agencies. These agencies device management experts to support their auditors or internal auditors, and thereby provide the additional expertise and mentorship needed.
Third-party agencies have auditors from several geographic locations. Therefore, agencies hire auditors from a region of their choice to maximize efficiency and reduce costs.
Third-party agencies have well-developed and exhaustive processes to carry out audits. These audits are based on standard and proven practices and are developed over time with every tweak in compliance requirements.
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Outsource2india has over 24 years of experience in compliance services. We are driven by experts with in-depth knowledge and expertise in all GxP areas that you may need to comply with regulatory requirements. Our targeted compliance management process entails a host of end-to-end requirements i.e. from document creation to data integrity, from auditing to inspection, and from advisory to mock drills for regulatory checks.
If your business is looking for comprehensive end-to-end GxP compliance services in India, get in touch with our experts now.