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.
Copyright © ALTIUS PHARMA CS 2016
