Hyperion Pharma
Hyperion Pharma Consultancy is dedicated to providing expert guidance and support in pharmaceutical, food, and medical device industries, focusing on GMP compliance, regulatory affairs, ISO-related quality management, and quality performance metrics. It actively monitors industry developments, regulatory updates, and global initiatives to ensure clients meet evolving standards and regulations. The company also engages in public consultations and stays informed about international regulatory plans, such as India's recruitment of GMP inspectors and China's draft guidance on data management, to advise clients on compliance strategies.
Industries
Nr. of Employees
small (1-50)
Hyperion Pharma
Ierápetra, Lasithi, Greece, Europe
Services
Design and delivery of on-site GMP training courses, including assessment of basic GMP knowledge and validation topics.
Preparation for and execution of customer and regulatory audits across multiple standards (EU GMP, GDP, ISO 13485, 21 CFR, IPEC), including mock audits and remediation planning.
Advisory services on interpretation and application of regulatory guidance and assistance with compliance strategy across jurisdictions.
Support and advice on process validation strategies and regulatory documentation for finished products, including interpretation of relevant regulatory guidance.
Audits and assessments of API and excipient suppliers (including overseas sites) to determine GMP compliance and suitability for use in clinical studies or commercial supply.
Advisory on serialization implementation, tamper-evidence and data matrix coding to meet regulatory serialization obligations and reduce counterfeit risk.
Design and delivery of on-site GMP training courses, including assessment of basic GMP knowledge and validation topics.
Preparation for and execution of customer and regulatory audits across multiple standards (EU GMP, GDP, ISO 13485, 21 CFR, IPEC), including mock audits and remediation planning.
Advisory services on interpretation and application of regulatory guidance and assistance with compliance strategy across jurisdictions.
Support and advice on process validation strategies and regulatory documentation for finished products, including interpretation of relevant regulatory guidance.
Audits and assessments of API and excipient suppliers (including overseas sites) to determine GMP compliance and suitability for use in clinical studies or commercial supply.
Advisory on serialization implementation, tamper-evidence and data matrix coding to meet regulatory serialization obligations and reduce counterfeit risk.
Expertise Areas
- GMP compliance and audit readiness
- Quality Management System implementation and performance monitoring
- Regulatory affairs and international guideline interpretation (EMA/PIC/S/ICH and national authorities)
- Process validation and control strategy development
Key Technologies
- Reverse osmosis and non‑distillation water purification for pharmaceutical use
- 2D data matrix serialization and GTIN-based product identification
- Audit trail and electronic signature systems for regulated data
- Quality Risk Management frameworks
News & Updates
Latest updates on PIC/S guidance documents including cross-contamination, risk assessment, and good distribution practice.
EMA clarifies its process for lifting GMP non-compliance statements, especially for sites in third countries.
ICH's Q11 Q&A document on drug substance development and manufacturing reaches Step 4 of the process.
Details on the cities applying to host the EMA after Brexit, including criteria and timeline.
EMA published a concept paper on updating guidance for water quality in pharmaceutical manufacturing.
A counterfeit batch of Harvoni® was identified in Germany, with details on the investigation and implications.
Latest updates on PIC/S guidance documents including cross-contamination, risk assessment, and good distribution practice.
EMA clarifies its process for lifting GMP non-compliance statements, especially for sites in third countries.
ICH's Q11 Q&A document on drug substance development and manufacturing reaches Step 4 of the process.
Details on the cities applying to host the EMA after Brexit, including criteria and timeline.
EMA published a concept paper on updating guidance for water quality in pharmaceutical manufacturing.
A counterfeit batch of Harvoni® was identified in Germany, with details on the investigation and implications.