© 2024 by Mares ITX GmbH.
At Mares ITX, we provide all the required information, relevant documents and conduct trials with trusted partners for reliability, robustness and scalability.
The process of providing necessary documents to conduct clinical trials along with adhering to an Ethics Committee Approval for ATMPs requires a detailed understanding of new-age medicinal products.
01
Ethics committee briefing document.
02
Investigator brochure.
03
Clinical trial applications.
Firstly, clinical trials require approval by the ethics committee and legal authorities. This committee is responsible for safeguarding the wellbeing and rights of involved participants. On the other hand, legal or competent authorities must comply with international legislation standards.
The European approval process requires multiple applications. However, here is the good part. At Mares, we guide sponsors/partners through every step of the EU approval process to obtain hassle-free assessments.
Since 2009, the European ATMP (Advanced Therapy Medicinal Product) regulation is implemented and monitors the approval of gene-therapy, somatic-cell therapy or any tissue-engineered products.
This particular approval offers a pan-European access for gaining market authorization for ATMPs.
Furthermore, the regulation paves the way for incentives (For example: Low fee for scientific consultation and fee deductions for SMEs) for pharmaceutical firms opting to produce cellular and molecule-based therapies.
Provide consultations and conduct scientific meetings.
Prepare regulatory documents.
Support clients during the period of authority review.
Monitor and correct deficient reports.
Clinical trials in Advanced Therapy Medicinal Products or ATMPs pose new challenges to participants, regulatory authorities and associated sponsors.
A deep understanding of ATMP technologies, regulatory requirements and logistical needs are important for designing, planning and conducting clinical trials successfully.
Convidia, our trusted partner, provides the necessary network, knowledge and experience to get clinical trials designed for best results.
According to Article 41 of the directive 2001/83/EC. "In order to have manufacturing authorization, the applicant/organization shall have at least one Qualified Person within the meaning of article 48".
As a partner, at Mares ITX, you are offered experienced QP services for monitoring & assessing Advanced Therapy Medicinal Products. Similarly, Mares also provides QP services to ATMPs released into the EU.
Auditing and inspecting GMP (Good Manufacturing Practices) of Biopharmaceuticals requires expertise at the highest level. Manufacturing authorities generally need their Qualified Persons on site.
To reduce workload, EU GMP allows QPs to refer to third-party audits that are conducted by qualified auditors.
This, therefore, saves time to inspect suppliers and contract manufacturers.
01
QP or Qualified Person services
02
Audit assistance for ATMP manufacturing
03
GMP compliance and audit services
During clinical trials, medicinal products in EU, which are manufactured outside EU need a mandatory import permit as well as an importing organization based in the EU.
An importing permit is basically a manufacturing permit for institutions/companies located outside EU, which includes the audit of the manufacturing site. Moreover, an importing institution releasing medicinal products into the EU, further requires a Qualified Person or QP.
On the other hand, in case of any legal complications, according to EU regulations, a legal representative inside the EU is a must.
01
Assistance with permits.
02
QP services.
03
Legal representative services.
What's more - Mares takes pride in providing the best packages for clients that include consulting with hospitals, investigators and analytical facilities.
At Mares ITX, we provide all the required information, relevant documents and conduct trials with trusted partners for reliability, robustness and scalability.
The process of providing necessary documents to conduct clinical trials along with adhering to an Ethics Committee Approval for ATMPs requires a detailed understanding of new-age medicinal products.
01
Ethics committee briefing document.
02
Investigator brochure.
03
Clinical trial applications.
Firstly, clinical trials require approval by the ethics committee and legal authorities. This committee is responsible for safeguarding the wellbeing and rights of involved participants. On the other hand, legal or competent authorities must comply with international legislation standards.
The European approval process requires multiple applications. However, here is the good part. At Mares, we guide sponsors/partners through every step of the EU approval process to obtain hassle-free assessments.
Since 2009, the European ATMP (Advanced Therapy Medicinal Product) regulation is implemented and monitors the approval of gene-therapy, somatic-cell therapy or any tissue-engineered products.
This particular approval offers a pan-European access for gaining market authorization for ATMPs.
Furthermore, the regulation paves the way for incentives (For example: Low fee for scientific consultation and fee deductions for SMEs) for pharmaceutical firms opting to produce cellular and molecule-based therapies.
Provide consultations and conduct scientific meetings.
Prepare regulatory documents.
Support clients during the period of authority review.
Monitor and correct deficient reports.
Clinical trials in Advanced Therapy Medicinal Products or ATMPs pose new challenges to participants, regulatory authorities and associated sponsors.
A deep understanding of ATMP technologies, regulatory requirements and logistical needs are important for designing, planning and conducting clinical trials successfully.
Convidia, our trusted partner, provides the necessary network, knowledge and experience to get clinical trials designed for best results.
According to Article 41 of the directive 2001/83/EC. "In order to have manufacturing authorization, the applicant/organization shall have at least one Qualified Person within the meaning of article 48".
As a partner, at Mares ITX, you are offered experienced QP services for monitoring & assessing Advanced Therapy Medicinal Products. Similarly, Mares also provides QP services to ATMPs released into the EU.
Auditing and inspecting GMP (Good Manufacturing Practices) of Biopharmaceuticals requires expertise at the highest level. Manufacturing authorities generally need their Qualified Persons on site.
To reduce workload, EU GMP allows QPs to refer to third-party audits that are conducted by qualified auditors.
This, therefore, saves time to inspect suppliers and contract manufacturers.
01
QP or Qualified Person services
02
Audit assistance for ATMP manufacturing
03
GMP compliance and audit services
During clinical trials, medicinal products in EU, which are manufactured outside EU need a mandatory import permit as well as an importing organization based in the EU.
An importing permit is basically a manufacturing permit for institutions/companies located outside EU, which includes the audit of the manufacturing site. Moreover, an importing institution releasing medicinal products into the EU, further requires a Qualified Person or QP.
On the other hand, in case of any legal complications, according to EU regulations, a legal representative inside the EU is a must.
01
Assistance with permits.
02
QP services.
03
Legal representative services.
What's more - Mares takes pride in providing the best packages for clients that include consulting with hospitals, investigators and analytical facilities.