About Hemex

Hemex supports young start-ups as well as established companies with a wide range of expertise in developing pharmaceutical products, medical devices and veterinary medicines. Our experts look back on a succesful career in the pharmaceutical and/or medtech industry and made pivotal contributions to the development and approval of several innovative products.


Our Services

Regulatory Affairs (RA)
  • MAA management and preparation - national / MRP / DCP / CP registrations
  • Scientific advice requests
  • Paediatric investigation plans
  • Orphan drug designation
  • SME status
  • FDA advisory committee preparation
  • CHMP oral explanations
Quality Assurance (QA)
  • Implementation of a Quality Management System (QMS)
  • cGxP audits
  • Pre-approval inspection preparation at sites
  • Mock inspections (FDA / EMA)
  • Monitoring and co-monitoring visits
  • SOP writing
  • ISO certifications
  • CAPA management
Supportive Functions (SF)
  • Long-term archiving and storage
  • Medical translations
  • Staff and investigator GxP trainings
  • Meeting planning
  • Secretarial support
  • Supply logistics
Medical Affairs (MA)
  • Clinical trial applications
  • Publishing and regulatory lifecycle management
  • IMPD clinical documents
  • Risk management plans
  • Pharmacovigilance system master files
  • Medical writing
Project Management (PM)
  • Pre-study investigational site selection
  • CRO co-ordination / management
  • Clinical trial management
  • Documentation management
  • Data management
  • IMP supply management
  • Other vendor management
Chemistry Manufacturing and Control (CMC)
  • CMC (Quality) Data Review and Gap Analysis
  • Process control, characterisation, analytical and bioanalytical methods, method validation
  • Comparability studies
  • IMPD Quality Documents

Pricing

Contact us today to get a free quote for your project.

Hemex offers a 100% transparent pricing model based on the number of hours required and the complexity of the project.


Clients have the possibility to be charged by an hourly rate, by a fixed price per assignment or by a retainer fee for continuous, flexible support.

Required pass-through costs are previously agreed with the customer.


Get In Touch

Let us know how we can support you. 

Please complete the contact form below or call us on +41 61 922 22 80.

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Address

Hemex AG
Tenum Building
Grammetstrasse 14
CH-4410 Liestal
Switzerland

Call Us

Tel +41 61 922 22 80
Mob +41 79 833 73 30