Our tailored services for Biotech start-ups
PLG provides full product lifecycle support, from Design to Post Market, of Biotech
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
- 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
Compliance
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
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