Because of our in-depth knowledge of business processes, ProductLife Group is able to manage communication among the various and complex project stakeholders, including the clinical, regulatory, quality, PMS team, manufacturing, and commercial. We provide advice and expertise on our clients’ processes or help them formalize their existing processes.

Global Strategy

Development Plan / Regulatory Go-To-Market Strategy

Related to targeted claims and market: integrating regulatory / guidelines requirements / IP / markets / populations & claims – Target Product Profile

Gap Analysis

Date due diligence: CMC / Pre-Clinical / Clinical / Quality / Regulatory / IP

Market Access Strategy

Market Access

  • HTA, Pricing & Reimbursement per country (P&R dossier, Budget Impact Model, etc.)

Marketing & commercial

  • Product promotion, KOL, Hospital collaboration

Product Development

Preclinical & Clinical – Design

  • High-level due-diligence of preclinical or/and clinical data
  • Designing a preclinical / clinical development plan including Orphan Drug Designation, Pediatric Investigation Plan, Support in design of First-in-human trials, Compliance to ATMP or other guidelines, pharmacology and toxicology reports
  • Management of scientific advice meeting with targeted regulatory agency

Preclinical & Clinical – Operational

  • Lab/CRO selection & management: protocol development, oversight of all the activities managed by the CRO (responsibilities & SOPs), ensuring GLP / CGP and applicable regulatory guidance compliance

CTA / IND support

  • Preparation and submission

Safety Clinical

  • Resp. Person, Medical writing, Plan, Reports, Databases, Case management


  • CMC HealthCheck in eCTD format
  • CMC writing, ASMF, DMF, CEP, ICH Q3D, Modules 2.3 and 3

Manufacturing & Distribution Scheme

  • Manufacturing strategy, GMP, CDMO selection & MAT


Quality Compliance

  • Quality by design, GxP Agile & Cloud QMS

Regulatory Affairs & Operations

Common Technical Document (CTD)

  • Write Modules 1 to 5, eCTD support, QC CTD data, ICH guidelines

Product Registration

  • MAA / BLA submission

We support innovative start-ups/biotech

We support innovative start-ups/biotech

New Biological Drug Registration for a Non-EU Client

  • Selected the appropriate agency to conduct a SAM with
  • Prepared SAM materials including justifications for waivers for studies
  • Provided Product Development Plan and registration strategy for the EU market

Monoclonal Antibody Support

  • Conducted Pre-Clinical and Clinical Due Diligence on existing Data
  • Prepared and executed Delphi Panel to gather a consensus to create a robust development plan
  • Assisted with the preparation of the SAM package

Small Start-Up Company with NCE

  • Conducted due diligence for existing Pre-Clinical and Clinical data
  • Created a Development Plan based on the Gaps identified
  • Assisted in the selection and management of the CRO to perform the additional studies identified in the development plan

International Biotech MA Project

  • Provided an in-depth registration strategy
  • Provided a dedicated team to manage the multiple registration (17 additional markets)
  • Sourced and integrated local experts for each market to expedite the registration process