Services

Qualified person service

Qualified person service

EU Certification and batch release of sterile and non-sterile commercial products

The QP is a highly specialized and rigorously qualified role that oversees batch certification and release of medicinal products.

Our Team of Qualified Persons has strong knowledge, skills, and experience to provide consultancy, specific trainings, mentoring program for new QPs and audit of GxP vendors.

We are a holder of Manufacturing and Import Authorization issued by Bulgarian Drug Agency, which allows us to certify and release commercial batches of sterile and non-sterile medicinal products for our EU and non-EU clients.

We have a contract and a technical agreement with licensed EU laboratories for quality control of medicinal products.

We support our partners in complying with their duties as outlined in EU regulation.

Certification of investigational medicinal products (IMPs)

Since the QP is responsible for ensuring GMP compliance of the IMP as per the Clinical Trial Application (CTA) and IMP Dossier (IMPD) information, our QPs will support the approval process with QP declaration based on the IMP manufacturer audit, IMPD compliance check and technical release of IMPs.

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IMP Importation

IMP Importation

The company is a holder of Manufacturing and Import Authorization issued by Bulgarian Drug Agency, which allows us to import in EU and certify batches of investigational medicinal products.

We have a licensed EU warehouse which enables us to ensure proper IMPs storage and monitored transportation to clinical centers in Europe. We have a contract and quality agreement with relabeling site authorized to perform relabeling activities of IMPs.

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Auditing

Auditing

Our qualified auditors can support you with high level independent audit of your suppliers of APIs and primary packaging materials, your contract manufacturing site or contracted quality control laboratory. We guarantee strict confidentiality on all levels and absence of conflict of interest.

We are also capable of preparing your team for Health Authority Inspection or client audits. Our special training program “Psychology of auditing” will train your key staff how to behave during the audit or inspection. Proposed pre-inspection audit and our GAP assessment report will provide you with clear overview about your readiness and your compliance level.

We also can support your team during the HA inspections and CAPA plan preparation.

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QMS establishment and remediation

QMS establishment and remediation

We will ensure a dedicated remediation expert committed to your organization who will walk you through QMS establishment process.
We will guide you how to create and manage effective standard procedures and company policies.
We can support you with business improvement roadmap that will help you to become an even more successful and profitable company.
We will become an extension of your team and will guide you along the remediation pathway.
Our experts will help uncover the root cause of compliance issues, remediate them, and prevent recurrence so you are compliant.

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GxP Trainings

GxP Trainings

Our high-level trainers are qualified to conduct GxP trainings.
Our interactive training materials are valuable tools for improving GxP knowledge of your staff.
Your team will be able to learn from the long years of professional experience of our experts. We will create special training program based on your current needs and reflecting your company specifics.
Our special training program “Psychology of auditing” will train your key staff how to behave during audit or inspection.
The effectiveness of this program was confirmed during the several successful Health Authority Inspections.

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Other

Other activities

We are successfully managing the following activities for different pharmaceutical companies:

  • Vendors Qualification
  • Complaints’ handling
  • Mock recall exercise
  • Warehouse temperature mapping
  • Business continuity plan

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