Pascal Winnen
CEO

 

Hemex supports start-ups as well as established biotech and medical device companies with a wide range of expertise, either in-house or via our network of dedicated partners and affiliates. Our experts have several decades of combined experience in the pharmaceutical and medtech industry with pivotal contributions to the development and approval of innovative products.

We support you in your interactions with the investor community and we also offer interesting collaboration programs, including seed funding.


 

regulatory affairs pharma

  • Investigational New Drug (IND) application preparation and submission
  • Market Authorization Application (MAA) preparation and submission
  • New Drug Application (NDA) preparation and submission
  • National / MRP / DCP / CP registrations
  • Scientific Advice requests
  • Orphan Drug Designation requests EMA/FDA
  • Pediatric Investigation Plan (PIP) submissions
  • Pre-submission meeting preparation and support
  • Fast Track strategy support
  • Local representation in Switzerland, the European Union, and the United States
  • SME status application / Small Business Waiver / PDUFA
  • FDA advisory committee preparation
  • CHMP oral explanations
  • GDPR compliance check
More INFO

chemistry & manufacturing

  • CMC (Quality) Data Review and Gap Analysis
  • Process control & characterization
  • Analytical and bioanalytical methods validation
  • Extractables and Leachables
  • Photostability studies
  • Technology transfers
  • Comparability studies
  • Investigational Medicinal Product Dossier (IMPD) quality documentation writing
  • New Drug Application (NDA) writing of Module 2 & 3
  • Clincial trial supply logistics
  • Serialization setup
more info

quality assurance / Qualified person

  • Implementation of a Quality Management System (QMS) + guidance through inspection
  • cGxP audits
  • Pre-approval inspection preparation at sites
  • Mock inspections (FDA / EMA)
  • Release of investigational product
  • Release of commercial product batches
  • Standard Operating Procedure (SOP) writing
  • ISO certification management (9001, 13485)
  • CAPA management FDA483 resolution
  • Monitoring and co-monitoring visits
  • For-cause audits
  • Warning Letter remediation
More INFO

medical affairs

  • Clinical Trial Applications (CTA)
  • Investigational Medicinal Product Dossiers (IMPD)
  • Protocol and Investigator’s Brochure (IB) writing
  • Medical Monitoring (MM)
  • Writing Periodic Safety Update Reports (PSUR)
  • Writing Risk Management Plans (RMP)
  • Pharmacovigilance Site Master Files (PSMF)
  • Medical writing
  • and more…
more info

project managemenT

  • FREE Leadership Team delegation for “virtual” organizations
  • Local representation / affiliate set-up EU / CH / US including application for government support programs
  • Joint ventures
  • CRO co-ordination / management
  • Clinical trial management
  • Trial Master File (TMF) management
  • Data management
  • IMP supply management
  • Vendor management
  • Pre-study investigational site selection
  • Clinical Trial supplies import/export
  • Incubator/accelerator support (modular office space, business/scientific coaching, …)
  • Tax strategy support
More INFO

documentation & data management

  • Document repository systems
  • Team collaboration websites
  • eCTD review & publishing
  • Long-term archiving and storage
  • GDPR: EU representation (Art. 27 GDPR)
  • GDPR: Data Protection Officer (Art. 37 GDPR)
  • Medical writing (IB, PSUR, USPI, …)
  • Medical translations
more info

medical devices

  • Classification of your MD / AiMD / IVD device according to current MDD, AIMDD or IVDD and new MDR or IVDR
  • Technical File or/and Design Dossier submission under the current MDD, AIMD or IVDD
  • 510(k) clearance and PMA approval (US)
  • Regulatory approval strategy for your device (EU & US)
  • Selection of reference product or/and predicate device
  • Interpretation and implementation of new MDR & IVDR
  • Identification of the right Notified Body for your device
  • Interactions with Notified Body and other authorities
  • Lifecycle of medical device / conformity assessment
  • Post Market Surveillance
  • ISO 13485 Quality Management System compliance
  • UDI / Serialization setup
more info

Training & Workshops

  • Staff & Investigator GxP trainings
  • Diversity & Inclusion workshops
  • Investigator Meeting planning
  • Laboratory documentation: best practices
  • Customer Service training
more info