Compliance and Regulatory Efficiency
KONTEKST provides the infrastructure to manage sensitive medical documentation and high-stakes data. We support global pharmaceutical and biotech companies in meeting strict regulatory requirements and maintaining safety standards across all markets.
Market Entry
Regulatory Compliance
Medical Documentation
Pharmacovigilance Speed and Precision
Pharmacovigilance Speed and Precision
We handle the rapid delivery of safety reports, including PSURs, SUSARs, and Adverse Event documentation. Our workflows are designed for short turnarounds to meet mandatory regulatory deadlines.
We handle the rapid delivery of safety reports, including PSURs, SUSARs, and Adverse Event documentation. Our workflows are designed for short turnarounds to meet mandatory regulatory deadlines.
Specialized Quality Control
Specialized Quality Control
All projects undergo internal verification for correctness and completeness. We provide additional validation through back-reading and reconciliation to ensure the absolute accuracy of clinical and technical documents.
All projects undergo internal verification for correctness and completeness. We provide additional validation through back-reading and reconciliation to ensure the absolute accuracy of clinical and technical documents.
Regulatory Content Management
Regulatory Content Management
we manage the preparation of Summaries of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and drug manufacturing descriptions. We ensure these documents comply with the requirements of the Ministry of Health and other global authorities.
we manage the preparation of Summaries of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and drug manufacturing descriptions. We ensure these documents comply with the requirements of the Ministry of Health and other global authorities.
Volume and Scale
Volume and Scale
We manage over 60,000 pages of medical and pharmaceutical documentation annually. Our capacity allows us to handle large-scale multilingual projects in 250 language combinations simultaneously.
We manage over 60,000 pages of medical and pharmaceutical documentation annually. Our capacity allows us to handle large-scale multilingual projects in 250 language combinations simultaneously.
Expert Resources
Expert Resources
Your projects are managed by medical professionals with specialized knowledge of the pharmaceutical industry. This ensures technical consistency in legal acts, medical publications, and audit documentation.
Your projects are managed by medical professionals with specialized knowledge of the pharmaceutical industry. This ensures technical consistency in legal acts, medical publications, and audit documentation.
Key Benefits for Pharma & Biotech Partners
Key Benefits for Pharma & Biotech Partners
Key Benefits for Pharma & Biotech Partners
Top Global CROs
Top Global CROs
Top Global CROs
On-Time Delivery
On-Time Delivery
On-Time Delivery
Data Security
Data Security
Data Security
Language Pairs
Language Pairs
Language Pairs
Response Time
Response Time
Response Time
Complaint Rate
Complaint Rate
Complaint Rate
Speed Up Regulated
Communication
KONTEKST delivers specialized language and content services
designed for clinical and regulated environments.
Speed Up Regulated
Communication
KONTEKST delivers specialized language and content services
designed for clinical and regulated environments.