Alhena’s team members have a distinct set of knowledge and experience in assisting start-ups and small and medium enterprises (SMEs), which needs are different than the ones of large pharmaceutical companies in terms of consultancy services and operational supports. In order to provide the best services possible, Alhena consult adapts its services to its clients’ needs and works with dedicated experts, as required by the projects.

Both types of companies develop molecules, biologics from research to market. However, there is such a contrast in terms of manpower and R&D financial investments, and start-ups require a different level of care when it comes to risk assessment. 

Whereas SME will require more hands-on support on all aspects of development (strategy, operational supports …), a large pharmaceutical company will require more ad hoc help throughout periods of increased activity. All these types of services are provided by Alhena.

 

* For EMA, the SME criteria are set out in Commission Recommendation 2003/361/EC.

 

START-UP/SME

 

A true partner to work in close collaboration, to ensure your product moves forward in order to outlicense it or to take it to market, by working on stand-alone tasks or on the entire project.

For start-up implemented outside the EU, Alhena can act as the local EU partner for the agencies and work on the EU product development in close collaboration with the non EU Head Quarter until implementation in EU.

 

TRANSITION FROM RESEARCH TO DEVELOPMENT

 

• Support for the positioning of the « targeted product », versus disease, existing market, similar product already under development => Target Product Profile

• Design plan and costs until the first human proof of concept study encompassing regulatory pre-requisites
  • Advice on pre-requisites to go from your non clinical proof of concept to the human proof of concept
    • Listing of pharmacology and toxicology studies to be completed before first administration in humans
    • Molecule definition/formulation work
  • 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 proof of concept

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

 

FROM EARLY DEVELOPMENT TO FULL DEVELOPMENT

 

• Agreement on development and registration plan by regulatory agencies
  • Preparation of Briefing package for scientific advice
    • Nonclinical studies to support first clinical studies
    • Drug substance and drug product specification, shelf life, registration data package  
    • Clinical protocol for the first studies
    • Clinical studies to support registration
  • Management of agency meetings
  • Be a regulatory team member during the meetings

• Advice, preparation, compilation and submission to competent authorities/EMA of:
  • Orphan Drug Designation (ODD)
  • Pediatric Investigational Plan (PIP)
  • Clinical Trial Applications (CTA)
  • Investigational medicinal product dossier (IMPD)
  • Investigator Brochure (IB)

• Operational management
  • Management of subcontractors & readiness for commercial support
    • Nonclinical
    • Clinical
    • CMC: drug substance manufacturing, formulation development, drug product manufacturing, according to GLP, GMP
  • Ensure timelines and budgets are respected

• Due Diligence support
  • Management of team
  • Preparation of documentation
  • Be a company team member during due diligence review

• Organizational support
  • Support in the growth of organization by providing assistance including help with hiring and transferring knowledge

 

EARLY ACCESS PROGRAMS IN FRANCE (ATU)

 

• • Advice & strategy of your ATU projects
  • Project management of ATU projects
  • Preparation or review of your ATU application for ANSM, including the protocol for therapeutic use (PUT) and medical justification
  • Submission of ATU dossiers to ANSM and follow up until ATU is granted

 

REGISTRATION

 

• Regulatory strategy
• Manage eCTD activities until approval: coordination, review, compilation & submission of CTD dossiers for EU registration (MRP, DCP, CP)
  • Writing of CTD sections or
  • Identify team to write, publish and file complete eCTD
  • Responses to Agencies questions

• Support company and/or manage regulatory agencies meeting before filing
  • Preparation of Briefing package
  • Management of agency meetings
  • Be a regulatory team member during the meetings

• At filing, identify the risk and manage the gaps identified during the review process

 

LAUNCH ACTIVITIES

 

• Support company for launch in France
  • Preparation of Briefing package for HAS/CEPS
  • Identification of the “WholeSaler” that will be compliant for France
    Support in setting up the “Exploitant” status in France if needed
  • Advice/support on sales force qualification
  • Review of promotional materials

•  Support company for launch in Europe
  • Review of promotional materials

 

PRODUCT MAINTENANCE

 

• Variations
  • Filing strategy (advice on classification, grouping/worksharing)
  • Write, compile and file variations to Regulatory Authorities
• Renewals/PBRER (PSURs)
  • Write, compile and file to Regulatory Authorities

• CMC compliance
  • Gap analysis (dossier vs CMO)
  • Write/update CTD sections accordingly

 

LARGE COMPANIES

 

 

DEVELOPMENT

 

• Support for writing, review, compile your regulatory documents for:
  • Scientific advice
  • Orphan drug designation
  • Pediatric investigational plan
  • Clinical trial applications
  • ATU dossiers

 

REGISTRATION

 

• Support for writing, review, compile regulatory documents for your MAA application

 

LAUNCH ACTIVITIES

 

• Support company for launch in France
  • Preparation of Briefing package for HAS/CEPS
  • Advice/support on sales force qualification
  • Review of promotional materials
• Support company for launch in Europe
  • Review of promotional materials

 

PRODUCT MAINTENANCE

 

• Variations
  • Filing strategy (advice on classification, grouping/worksharing)
  • Write, compile and file variations to Regulatory Authorities
• Renewals/PBRERs (PSURs)
  • Write, compile and file to Regulatory Authorities

• CMC compliance
  • Gap analysis (dossier vs CMO)
  • Write/update CTD sections accordingly

• Update of existing files (e.g. consolidation of module 3, reformatting NtA into CTD)