Your Trusted Partner in pharmaceutical Regulatory Compliance and Clinical Excellence
Avanteva Solutions (OPC) Pvt. Ltd. is a leading service
provider offering exceptional pharmaceutical regulatory
services, specializing in Computer System Validations (CSV), Clinical Translation services, Courses & Trainings.
With our dedicated
team, we enhanced our offerings and continued to stay
at the forefront of industry requirements. With a proven
track record and strong dedication to excellence,we are
fully committed to supporting organizations like yours by
extending valuable services.
Our approach is unique which is a risk-based approach that helps
to enable life science industries to meet the regulatory requirements by
eliminating GxP compliance risk.
Our consultants have rich domain
experience and are recognized as the gold standard for maintaining a
consistent Quality Management System with their expertise in various
Pharmaceutical organizations & CRO’s to reduce compliance risk in the
regulatory framework.
We offer cost-effective, timely and professional solutions with quick turnaround times, ensuring the highest quality and consistent results.
We concentrate primarily on customer-centric approaches by delivering exemplary service to ensure great customer satisfaction.
We follow top-class standards to compliance with industry specifications to offer excellent and quality service
We strive for excellence in knowledge. We believe every day is a fresh day and the opportunity to learn new things and we believe in result-oriented practices.
We strive to meet deadlines for every project that comes in.
“AVANTEVA’s dedication to developing unique validation plans for each Computer System Validation project truly sets them apart. Their tailored approach ensured our systems received a customized validation framework, perfectly aligned with our specific needs.”
– A Global Biopharmaceutical company
“They seamlessly integrate USFDA 21 CFR Part 11 guidelines into our validation protocols, following the ISPE GAMP5 approach with precision. Their expertise in regulatory compliance provided us with confidence in meeting stringent industry standards.”
– Top 9 Pharma Company in India
“Their expertise in Risk Management was invaluable to our project’s success. Their meticulous GAP Analysis uncovered critical vulnerabilities in our systems, allowing us to address potential risks proactively and maintain operational integrity.”
– A Pharma company producing Injectables & Oncology products
“Avanteva Solutions is expertise in Computer System Application Software Validation, Win Non Lin, SAS and helps organizations better manage & comply with regulatory requirements”.
– A Clinical expert of a reputed CRO
“Their Project Trackers provided invaluable transparency and clarity throughout our validation project. This innovative tool allowed us to monitor progress in real-time, ensuring seamless coordination across departments. It exemplifies AVANTEVA’s commitment to efficiency and client-centric solutions, making them an indispensable partner in our regulatory compliance efforts.”
– R & D & Manufacturing Pharma Company
“Their team of certified translators are true experts in their field. Their diverse skills ensure precise and reliable translations for every project. We rely on their proficiency to maintain the integrity and accuracy of our documents.”
– A Clinical domain based from Hyderabad
In March of 1997, the United States FDA issued regulations that established the criteria for the acceptance by the FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents. While our focus is on medical device companies and the compliance of their quality systems with this regulation, the rules also apply to companies in pharma, biotech, biologics developers, and other FDA-regulated industries. These laws are codified as Part 11 of Title 21 in the Code of Federal Regulations, or 21 CFR Part 11, or Part 11 for shorthand.
Part 11 applies to drug manufacturers, biotech companies, medical device manufacturers, contract research organizations, and several other FDA-regulated industries (such as food and beverage manufacturing). Additionally, some organizations that are not FDA-regulated may choose to use Part 11 as a guide to assure that they are utilizing good processes for managing their electronic training records and other documents.
Both are the set of guidelines which are used to validate a computer based software used in a pharma manufacturing companies.
If your documents needed for translation are ready with you, you can simply mail us to translation@avanteva.org and attach the document(s) to email. We shall keep the documents strictly confidence. Based on that, we will generate the quotation and send you.
We knew that the need for medical translations is always urgent! We aim to submit the translated documents as early as possible but not to the point where quality of translated document is compromised. Depending on the type of format of document and scientific information of the passage, we take adequate time and put our sincere efforts to get best outcomes. You can always reach us 24X7 if you have any urgency for submissions.
You can send us in any of the following document formats- MSWord or Adobe PDF formats.
