English Français
Altius Pharma CS

ALTIUS PHAMA CS consultants can provide you with the following services:

Development / Clinical Trials / Regulatory Affairs / Market Access / Medical Affairs / Business Development / Dossiers analysis / Quality / Transitional Management

  • Development
  • Strategic Analysis
  • Clinical Development Plan
  • Coordination: CMC / Preclinical Research / Proof of Concept / Clinical Research
  • Study Design
  • Project Management
  • Feasibility Studies
  • Clinical Trials
  • Protocol Design
  • Scientific Committee set up and Management (Steering Committee, Data and Safety Monitoring Board)
  • Regulatory Coordination for trial initiation (IMPD, Investigator’s Brochure, informed consent and other study related documents)
  • Specifications Definition for Tenders
  • Selection / Supervision of CROs
  • Clinico-Statistical Coordination
  • Writing of ICH Clinical Study Reports
  • Regulatory Affairs
  • From Clinical studies to Drug registration
  • Advice on registration procedures and priority assessment strategy: Breakthrough Therapy, Fast Track, Priority Review and Accelerated Approval for FDA, PRIME (PRIority MEdecine) Scheme for EMA
  • Organisation of Scientific Advice(s) with Regulatory Agencies (National Agency, EMA, FDA)
  • Bibliographic Applications or Abridged Applications (e.g. generics)
  • Orphan Drug Designation
  • Pediatric Investigation Plan (PIP)
  • Marketing Authorization 5-yearly renewal
  • Preparation of the Common Technical Document (CTD)
    With the help of a network of experts, preparation of quality modules and preclinical security
  • CTD relevant section writing coordination (modules 2.3, 2.4 and 2.6)
  • Data Collection (study reports)
  • Preparation of Modules 3 and 4
  • Preparation of Efficacy Modules
  • Writing of CTD relevant Modules (2.5, Clinical Overview and 2.7, Clinical Summary)
  • Preparation of Module 5
  • Risk Management Plan(RMP)
  • Preparation of RMP in relationship with Applicant
  • Definition of Risks
  • Epidemiologic Search
  • Document Preparation
  • Market Access
  • Epidemiologic Research (literature reviews and analyses)
  • Preparation of Technical File for Reimbursement (French Transparency Commission, French CNEDiMTS, NICE…)
  • Scientific Board Set Up and Scientific Secretariat
  • Medical Affairs
  • Post-Launch Follow-Up
  • Medical Input for Life Cycle Management
  • Benefit /Risk Report
  • Risk Management Plan
  • Re-assessment of « SMR » following French Transparency Commission Request
  • Scientific Communication and Training
  • Manuscripts, Posters, Slides Writing
  • Training Documents (internal and external) writing
  • Product Monograph Writing
  • Boards of experts / Scientific Advisory Board
  • Opinion Leaders Coordination for Medical Symposia
  • Speakers Training
  • Scientific Board Secretariat
  • Congress Reports
  • Pharmacovigilance
  • Writing of PSURs and DSURs
  • Business Development / Dossiers analysis
  • Dossiers Analysis for Purchase / Licensing (Product Assessment, Scientific Analysis of the Medical Field, of the Disease and of the Competitors)
  • Due-Diligence
  • Quality
  • Development of Quality Systems
  • Writing and Review of Quality Documents
  • Transitional Management
  • Management Support, Manager Replacement or Starting Up of a Team
  • Operational Team Management (Clinical Operations, Project Management)

Research Tax Credit
ALTIUS PHARMA CS is approved as a private organization for research according to section II d bis of article 244 quater B of the French General Tax Code.

Research expenses with ALTIUS PHARMA CS may be thus eligible to Research Tax Credit.