About Us

Our company was founded back in 2016 by a group of highly qualified and experienced pharmaceutical business professionals. We are aimed at rendering services to local and international companies using our knowledge and approach.

That is our mission. That is what we are fully devoted to.
At MegaLek, our range of services under the clinical research domain is executed with comprehensive efforts, to surely deliver positive results.

We are very close with many companies from Europe, CIS, Russian Federation and the USA.

Pharmacovigilance

MegaLek, as a Pharmacovigilance Partner, provides end-to-end pharmacovigilance services to precisely compliment client’s needs in either Europe, CIS, and the Russian Federation or the USA .

Fully or partially outsourcing the pharmacovigilance services:

– At MegaLek, pharmacovigilance is stipulated by the Standard Operational Procedures that are supported by Quality Management System;

– We are familiar with legislation of Europe, CIS, Russian Federation and the USA and experienced accordingly ;

– We are providing full compliance with the regulatory requirements;

– Qualified Person Responsible for Pharmacovigilance and his back-up is always in touch;

– We are available for you 24\7;

– Checking youк Company’s readiness for audits and inspections.

Monitoring of scientific and medical books and periodicals as well as regulatory agencies web-sites and other internet-resources so that you might be aware of the latest information regarding your products:

– We can monitor any country where your products are registered;

-Transparency and traceability;

-We may use either our or your SOPs.

Development and implementation of Pharmacovigilance Unit in your company:

– We can either develop the whole thing of your Vigilance Unit or may assist at any stage;

– Delivering the full compliance with the regulatory requirements;

– Committed to enhance quality of your SOPs, logs, forms, and etc., as per your Quality Management System;

– Train with MegaLek! We provide focused, comprehensive trainings and documentation, which leads to a successful trial.

Medical Data Management within clinical trials:

– Data monitoring with medical evaluation;

– Cooperation with Safety Data Monitoring Committee and medical unit of Sponsor

– AE and SAE Data Management and evaluation.

We are also good in:

– Risk Management Plan for registration dossier;

– PV Master file maintenance;

– Periodic Safety Reports development;

– PV unit audit;

– Assisting in preparation for audits of central offices and regulatory inspections.

– Cooperation with regulatory agencies.

We offer integrated solutions. Your need to comply with regulations and satisfaction are our opportunities to demonstrate our expertise.
 

Trainings

At MegaLek, not only do we develop training materials, we can also perform potent teaching of:

– pharmaceutical companies’ staff;

– study sites personnel;

– junior clinical trial associates and graduates

Out trainers are experienced in both local and international studies

Training materials are designed with due regard to the audience’s experience. Our methodology comprises theoretical information, practice, and knowledge testing, both initial and final. Those who complete the training are awarded certificate.

Our trainings are devoted to all aspects of pharmaceutical industry.

Audits

At MegaLek we are experienced enough to audit any aspects of pharmaceutical industry; at that Corrective Action and Preventative Action is issued.

In Europe, CIS, Russian Federation and the USA, we perform periodical, independent, internal and external audits of the following:

– GCP –Clinical trials conduction Read more >>

Audit of Contract Research Organizations to estimate their qualification and operations’ control.
Audit of clinical trial (TMF maintenance, clinical sites, study documents, plans and their execution, SOP compliance, data quality, pharmacovigilance, and third parties)
Every single audit terminates with the Corrective Action and Preventative Action
 
– GVP  – pharmacovigilance Read more >>

Audit of outsource organizations to estimate their qualification and operations’ control and regulatory and Sponsor’s requirements’ compliance.
Audit of representative offices to render permanent pharmacovigilance and estimate regulatory and Head Office requirements’ compliance.
Audit of Registration Certificate to estimate regulatory and Quality Management system compliance
 
– GDP – drugs distribution Read more >>

Audit of depots and distributors to estimate regulatory and Sponsor’s requirements’ compliance.
Every single audit terminates with the Corrective Action And Preventative Action.
 
– GMP – drug manufacturing Read more >>

Audit of manufacturing plants to estimate quality management, personnel management, facilities, documentation, manufacturing process, contract activities, reclamations and regulatory compliance.
Every single audit terminates with the Corrective Action And Preventative Action.
 
– GLP – laboratory practice Read more >>

Audit of local and central bioanalytical laboratories to estimate regulatory and Sponsor’s requirements’ compliance. 
Every single audit terminates with the Corrective Action And Preventative Action.
 
 – Quality management system. – Read more >>

Quality management system audit under ISO 9001:2015; self-developed systems are also welcomed. During the audit we estimate the system’s efficiency, key processes, personnel and paperflow to confirm its requirements’ compliance and quality. 
Every single audit terminates with the Corrective Action And Preventative Action.
 
 – Assistance in regulatory inspections and Head Offices audits – Read more >>

Delivering assistance to regulatory inspections and audits to demonstrate good compliance and successful results.
We offer integrated solutions. Your need to comply with regulations and satisfaction are our opportunities to demonstrate our expertise.

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