The complementary experience and skills of the Alhena team is one of the assets to assist pharmaceutical companies both in terms of advice and operational support.

Alhena consult adapts its services to its clients’ needs and works with dedicated experts, as required by the projects.

From hands-on support on all aspects of development (strategy, operational support …) to ad hoc help throughout periods of increased activity, the Alhena team is here to guide you through your projects.

 

 

DRUG DEVELOPMENT

 

• Market positioning strategy.
• Design CMC, preclinical & clinical development plan until registration encompassing regulatory pre-requisites
  • Advice on pre-requisites linked to the stage of development
  • Identification of subcontractor for drug substance and drug product manufacturing for GMP and GLP studies
  • Identification of subcontractor for non-clinical GLP studies
  • Identification of subcontractor for clinical studies

• Support for the preparation of packages for agency meetings and/or investors

 

EUROPEAN REGULATORY AFFAIRS

 

DEVELOPPEMENT

• Regulatory strategy, advice & regulatory roadmap from end of preclinical phase until MAA
• Advice, preparation, compilation and submission to Competent Authorities/EMA of:
  • Investigational Medicinal Product Dossier (IMPD) for Clinical Trial Application (CTA)
  • Scientific Advice for EU Regulatory Agencies
  • Orphan drug designation (ODD)
  • Pediatric investigational plan (PIP))

REGISTRATION

• Regulatory strategy
• Coordination, review, compilation & submission of CTD dossiers for EU registration (MRP, DCP, CP)
• Meetings with Agencies
• Responses to Agencies questions
• Review of CTD sections
  • CMC, pre-clinical & clinical,
  • Risk management plan
  • SmPC, labelling & package leaflet
  • Risk analysis and gaps identification of MAA dossiers

PHARMACEUTICAL RESPONSIBILITY – SPECIFIC SUPPORT IN FRANCE

• Compliance of Promotional activities:
  • Control of advertising and sales promotion
  • French sunshine act (DMOS)
  • Advice in the certification of sales representatives (Charte de l’information)
• Advice, preparation, compilation and submission of “Exploitant” dossier
• Quality Management for “Exploitants” in France
  • Gap analysis
  • Review & update of SOPs
  • Audits for “Exploitant” activities
• Provision of a deputy Chief Pharmaceutical Officer (“Pharmacien Responsable intérimaire” – PRI)

 

PROJECT MANAGEMENT

 

• Development roadmap, strategic input of projects in development
• Elaboration of global R&D plan and budget
• Management of global R&D projects from late stage research to market
• Plan and track project timings & cost.
• Manage Due Diligence up to a recommendation
• Management of CMOs & CROs
• MAA dossiers preparation (regulatory, scientific writing & publishing)
• Due diligence”until recommendation

 

EARLY ACCESS IN FRANCE

 

• Advice & strategy
• Global project management
• Support for the pre-submission meeting with ANSM and HAS
• Writing and compilation of the application dossier for the Early Access Program request (called AP in France) and compassionate use (called AC in France) including therapeutic use Protocol (PUT), taking into account the issues of the common law file
• Follow-up of the Early Access, amendment, renewal and periodic reports

 

PHARMACOVIGILANCE

 

• PV quality system support: set-up and advice
• Audit: company and third-party provider
• Provision of EUQPPV and French QPPV
• Writing of periodic safety reports (PSUR/DSUR), Risk Management Plan…