Clinical Trials & QA Services
We are a pharmaceutical consulting company and a registered CRO that conducts Clinical Trials from initiation to closure and helps organizations set effective QMS.
A quick list of services we offer:
OUTSOURCING:
Your toolset for increasing growth
Outsourcing is an excellent way to access resources and expertise quickly without capital investment or long-term commitment.
Using the services of a contractor, you will be able to deal with the peaks and troughs of product development and focus on your ‘core business’.
We can help your organisation make better – informed decisions and understand the risk profile from a regulatory and quality perspective.
We provide business solutions for
SPONSOR
Non-compliance has a profound effect on cost, reputation and the lives of your company customers or patients.
CROs
Newer business models are evolving as CROs (Contract Research Organisation) are increasingly entering strategic partnerships and alliances.
WHOLESALE
Pharmaceutical distributors play an important role to assure the quality of medicines along the supply chain.
We’re changing the way pharmaceutical organisations work by helping them improve their QMS with our QA outsourcing services.
1. Minimize the number of full-time staff
In other words, it is actually economical than having one of your own members of staff performing QA tasks.
For example, performing an audit takes much more time and effort than just being on site. During these activities, your valuable staff will not be able to tackle their regular tasks, which could create a backlog and increase work-related stress.
2. QA tasks will be conducted in a timely manner
It is cost-effective to hire professional QA staff because of their ability to perform QA-related tasks much faster than people who are performing it as an additional work task due to reasons such as experience and the frequency in which they perform them.
3. Flexibility: Resources when you need them
When you hire additional staff for audits, you run the risk of not having sufficient work for them later on. By outsourcing these needs, you ensure a flexible and cost-effective approach without wasting resources. This way, you have your needs fulfilled when you want it and how you want it.
4. Consistency:
Up to date with regulatory compliance
The growing number of regulations and the frequency with which they are updated means that you have to invest a lot of time and effort in monitoring and evaluation. We provide a full- service “one-stop” solution for developing, implementing, assessing and optimising your QMS.
5. More objectiveness
We are very aware of the pressures that can be experienced within organizations regarding obtaining ‘favorable’ audit outcomes. As there is no working relationship between an auditor and the departments mentioned above, there is no direct or indirect pressure.
Confidentiality and Privacy Issues
Safeguarding confidential information is core to the services Proqlea Ltd. provide.
We are committed to protecting confidential and personal information, especially that of our clients and third parties. We continually monitor regulatory and legal requirements to support compliance.
Proqlea Ltd. have set guidelines, developed procedures and we periodically assess the effectiveness relating to confidentiality and privacy. Our steps in remaining secure, vigilant and resilient:
1. Understanding the risk environment
2. Implementing policies, procedures and controls designed to protect confidential and personal information
3. Responding to potential confidentiality and privacy incidents in a timely manner
4. Actively monitoring the effectiveness of confidentiality and privacy requirements across all levels of the organisation
Proqlea Ltd. is dedicated to complying with applicable privacy laws and regulations around the globe, including the European Union (EU) General Data Protection Regulation (GDPR). We regularly monitor for changes in privacy laws and regulations, and adjusts policies and procedures when appropriate.
Our QA Director explains why you should outsource QA services
Josipa Ljubičić is QA Director and Principal GCP and GVP auditor at Proqlea Ltd. She has conducted more than 80 sponsor audits over the years with more than 20 unique audit types and mock inspections.
See Josipa’s Linkedin Profile for more information on her work expirience in “QA World”.
We help organisations get to market faster.
Proqlea Ltd. is the only Croatian certified CRO.
Our employees are certificated GCP and GVP auditors with 15 years of experience.
We work on-site and provide other auditing methods such as virtual/remote auditing or paper-based auditing.
We strongly encourage best communication between all parties concerned.
We operate worldwide. So far, we’ve provided our services to clients from the US, UK, Germany, France, Croatia, Macedonia, Singapore, Netherlands, Slovenia, Serbia, Bosnia and Herzegovina.
We offer cost-effective process options without compromising the objective of product quality.
Trusted by great pharmaceutical companies
Quality is about conforming to a standard.
How can we help?
Primary services Proqlea Ltd. offers:
- Providing a full-service “one-stop” solution for development, implementation, assessment and optimisation of QMS
- Performing GCP and GVP audits to ensure quality and adherence to regulatory and/or compliance requirements.
- Providing assistance with the development of a company’s QMS.
- Providing advisory services on regulatory and compliance.
Whenever you want to maximize your internal audit department, seeking help from Proqlea Ltd. is the cost-effective approach to evaluate and improve QMS in your organization. It can also become beneficial when you simply do not have enough staff to properly manage QA tasks, or your staff doesn’t have the full knowledge to perform comprehensive auditing strategies tailored to your organization’s objectives.
Request a quote using the form below
Allow us to create a customized plan
We’ll get you an accurate, no-obligation quote
Request a Quote
Please fill out the fields below and one of our QA specialists will contact you shortly.
Email: info@proqlea.com
Josipa Draženovića 2A, 10 090 Zagreb
Croatia
We will get back to you as soon as possible.
