Portfolio of Biotech Services

Sourcing & Supply of:

• Raw materials, starting materials & intermediates (mRNA,
  TIDES, payload, linkers) for biopharma
• Reference product for analytical comparability
  (full documentation package)

Procurement of qualified and experienced CDMOs for:

• Cell-line development
• Drug substance manufacturing

(Optional services for tech transfer and project management.)

Sourcing & Supply of:

• Comparators (reference product, active comparator) & co-medication for clinical trials

Procurement of qualified and experienced CDMOs for:

• Clinical trial manufacturing (IMP), incl. distribution
• Drug product manufacturing/commercial fill & finish
• Labelling and packaging

(Optional services for tech transfer and project management.)

Supply Chain Management:

• Clinical supply chain management
• 2-8°C storage & logistics
• Direct-to-patient distribution

Quality Services:

• Auditing service/Supplier qualification
• Inspection support (mock inspections, remediation &
  process improvements as outcome of the mock)
• Gap analyses & optimization of QMS
• EU Import of biotech products (IMPs)
• QP release of IMP (in-house EU QP)

Regulatory Services:

• Support in scientific advice procedures
• Dossier/IMPD evaluation, writing clinical & non-clinical overviews
• Compilation and publishing (in-house eCTD publishing)
• Submission management & communication with authorities

Licensing services:

• Identification of potential partners in global Midas network
• Support for out-licensing, partnering and dealmaking activities
• Third-party due diligence support
• Asset evaluation and mock due diligence assessments

Supply Chain Management:

• Launch preparation
• Setup and management of the supply chain
• 2-8°C storage & logistics
• Order handling/forecasting & demand planning
• Local US agent for US commercial import and distribution
• Import/Export services

Wholesale/Distribution:

• Customer service
• Complaints & returns
• EU Wholesale release (In-house WRP)
• Warehouse & stock management incl. last mile distribution
• Re-packaging/Re-labelling, doctor sample production

Pharmaceutical Responsibility:

• EU-GMP compliant pharmaceutical importation
• EU market release/certification (in-house EU-QP)
• Acting as Marketing Authorisation Holder (MAH)
• Comprehensive pharmacovigilance services (in-house EU-QPPV)

Quality Services:

• Manufacturing batch record review & QP certification
  (EU QP release to market, Annex 16 Appendix II)
• QP confirmation of partial manufacturing
  (Release for further processing, Annex 16 Appendix I)
• Management of bonded warehouse (site of physical importation)
• Change control, complaint handling, recall processing
  by Midas global QM

Regulatory Services:

• Regulatory maintenance
  (variations/supplements, extension applications, renewals)