CliniQAl Consult Corp

QMS

Regardless of the company size, a streamlined, flexible, simple and effective Quality Management System (QMS) will support its business as well as bring added value to the company.

A small sized company would obviously have different needs as well as background in this area, when compared to a larger sized company. Nevertheless, the principles are the same. A simplified pyramid that reflects the company ideology and enables the individual employee, as well the company in general, to identify and perform each process most efficiently, in compliance and in the best interest of the company business. In case of a merger or an acquisition, a lot of the companies’ resources are utilized in order to harmonize a unified QMS. This is a cumbersome process and the success of these efforts are always in the focus of the authorities.

We can provide you with expert solutions in order to either establish a system or optimize the existing one in order to improve the cost efficiency.

clinical QA

For many small sized companies, the shift from non-clinical research to clinical development can be an overwhelming step. Considering the resources needed to adapt to a more regulated area, where the overall responsibility always resides with the sponsor, the company should consider each step carefully in order to get it right the first time and, consequently, minimize the cost of development activities as much as possible.

Moving forward into following stages of the development introduces several challenges of a more complex character. Even upon registration of the drug, new indications and other relevant aspects of the drug can be investigated through post-marketing investigations.

Throughout all these phases, ClniQAl Consult can assist you bringing the drug to the market in a fast and effective manner. We can help you through the design phase of your trial activities as well performing assessment activities in order for you to be assured that all operations are optimal and on the track. These assessments can be performed as audits of the facilities and personnel, review of documents (including relevant feed-back) etc.

audits

One of the most common and effective ways of assuring that operations are adequately designed and correctly performed is to conduct an audit of the relevant area.

An audit is a systematic and independent examination of the activities and documents in focus in order to determine whether the evaluated activities were conducted, and the data were recorded, analyzed and accurately reported according to all the applicable requirements.

CliniQAl Consult auditors are all ISO 9001:2000 certified Lead Auditors, who with focus on involvement of management will provide you with relevant information to perform the most efficient risk assessment and identify the adequate following steps.

pre-audit

Anyone operating within the pharmaceutical field can become subject to a regulatory inspection or an external audit. Not all personnel or functions are used to act as an auditee and it is always a healthy policy to exercise the routines that an inspector/auditor would go through internally, beforehand.

CliniQAl Consult has the expertise to perform a mock inspection or a pre-audit in order for the auditee to become strategically as well as mentally prepared for the external visit. We will help you to identify the system gaps, discrepancies and non-compliances before an external body does. We will help you, correct and update your systems, and prepare plans and next steps, in order for you to be able to demonstrate establishment of your sound path toward compliance.

CAPA

When the auditee receives an audit/inspection report the relevant management is responsible that the necessary follow-up activities are carried out in order to insure that the content of the report is adequately addressed. Corrective and Preventive Actions (CAPA) are expected to be performed by the relevant personnel.

It is important to allocate the needed resources to assure the adequacy of follow-up. However, the balance should be maintained, if excess resources should be eliminated.

CliniQAl Consult has the knowledge and expertise to help our clients to stay on the right track and use its resources most efficiently.

SOP

The world of pharmaceutical guidelines & regulations is a complex and, at times, incompatible environment. Interpretation of these requirements can vary a great deal and, depending on the framework, the solutions to comply with these requirements are diverse.

At CliniQAl Consult we try to understand your systems’ infrastructure and suggest solutions that adapt most successfully to them in order to support your business goals.

pharmacovigilance

Depicting the correct safety profile for a pharmaceutical drug is being highly prioritized by the regulatory bodies around the world. New legislations are issued continuously in order to clarify the requirements or even add to the existing ones. Designing an infrastructure that facilitates adequate detection of signals, performance of qualified assessments, categorizing the events/incidents, filing them in the correct manner and finally using the relevant data in order to detect possible trends requires resources as well as continuous maintenance.

With the risk-based approach in mind, CliniQAl Consult will support you in establishing as well as maintaining your pharmacovigilance systems.

outsourcing

We support you, when outsourcing is considered. This includes due diligence, vendor assessment, advice on/during the kick-off meeting and ongoing performance assessment through audits etc.

The pharmaceutical development is leaning heavily towards collaboration between different company’s. The cost of drug development and the complexity of the world of pharmaceutical development, makes most companies realize the need of more financial power and environment know-how, than they posses internally.

CliniQAl Consult can help you to identify the most suitable partner for your future collaboration.

validation

Validation activities are often some of the most costly undertakings a company or department goes through. Choosing the right validation path and identifying the correct critical milestones in the process are crucial for a successful and compliant validation outcome.

Equipped with the correct risk-assessment tools, our consultants can provide you guidance or manage your validation project towards success.

training & presentations

CliniQAl Consult has Senior staff with the correct mind set and adequate experience to help, when you need to train your staff or give presentations to external guests. Following topics and forums are examples of the areas the training or the presentation can be given:
- GCP principles and regulations (e.g. at an Investigators’ Meeting)
- Validation principles
- Quality Management (QA/QC)
- Audits & Inspections
- Drug Safety