Our CDMO services

From integrated pharmaceutical R&D and production to quality assurance, finance and regulatory guidance, discover our comprehensive services to ensure a seamless and scalable journey from your long-acting idea to the market.

 

Drug Development Services

Pharmaceutical development 

Our team combines expertise in pre-formulation activities and drug formulation development with an understanding of commercial pharmaceutical manufacturing processes for long-acting combined products:

  • Feasibility studies
  • Pre-formulation activities
  • Drug formulation development
  • High-throughput screening capacities
  • Process development
  • Non-Clinical batches manufacturing
Pharmaceutical development 

Analytic method development

We provide development and validation of analytical methods for:

  • (High potent) active ingredients
  • Drug products and intermediates
  • Raw materials
  • Cleaning methods
  • Diffusion profiles
Analytic method development

Clinical supply manufacturing

We offer tailored and flexible clinical batches manufacturing services to ensure a successful launch of your Phase I, II and III clinical trials, according to your technical requirements and within your timeframe:

  • Scale-up
  • Technology transfer
  • Process validation and optimization
  • Clinical GMP manufacturing
  • QC and QP release
  • Clinical trials packaging and supply
Clinical supply manufacturing

Stability studies  

We offer stability testing under the International Conference on Harmonization (ICH) conditions and custom conditions.

  • Informal, formal, accelerated and long-term stability conditions
  • Physical, chemical and microbiological
  • Freeze-thaw studies
  • Specific studies (photostability, forced degradation, etc.)
  • Bulk holding time
Stability studies  

Contract manufacturing

With our state-of the art facilities, we are the flexible and scalable solution for your contract manufacturing needs from pilot batches to clinical trials materials, to full-scale commercial cGMP production of your long-acting products, meeting the most demanding requirements of today’s pharmaceutical industry.

Contract manufacturing

Logistics and supply chain

We cover all logistics and supply chain management activities you need to make a product available to your customers, from raw materials sourcing until delivery and invoice settlement for the final product:

  • Planning
  • Capacities availability and raw material supplies management
  • KPIs definition and monitoring for value chain optimization
Logistics and supply chain

Support Services

Project management

Our CMC experts  will collaborate with your teams from the very beginning of the project to make sure that all the development learnings transfer appropriately to full-scale manufacturing.

Throughout all development stages, our experts will work together closely to ensure the project is at all times aligned with your defined objectives.

Project management

Market access support

Our dedicated experts help you understand and integrate Market Access strategies throughout the development of your products, aligned with your business objectives:

  • Establish market access strategies, planification and coordination of activities
  • Mapping price and reimbursement pathways tailored to each market
  • Defining the product’s unique value, optimal price corridor, and strategic positioning
  • Identifying key stakeholders to influence and drive market access success

 

Market access support

Regulatory guidance

Our CDMO offers expert regulatory guidance to support clients in navigating the intricate requirements of pharmaceutical development in both the EU and US markets:

  • Strategic advice tailored to each development stage
  • Compliance with EU and US regulatory standards
  • Extensive experience in complex filings (INDs, NDAs, ANDAs, and MAAs)
  • Latest regulatory trends to streamline approval process
  • IMP Dossier preparation and follow-up

 

Regulatory guidance

Financial optimization  

Our finance experts are specialized in financial optimization, designed to help you maximize the value of your pharmaceutical development projects.

  • Over 20+ years securing funding
  • Strategic insights to align financial resources with development goals
  • Budget planning and cost control
  • Funding opportunities identification (including grants, partnerships, and investments)
Financial optimization  

Quality control  

Quality and compliance are at the heart of our activities at UniD, from development to manufacturing and commercialization. Our QC experts support all CDMO activities to ensure the delivery of high-quality standard products and provide quality oversight of:

  • Manufacturing, from receiving of raw materials until release of final product
  • Development and production testing activities
  • Third party quality oversight: regular audit of our supplier and contractors
Quality control  

Packaging  

Based on the product requirement and the patient’s experience, our experts can develop the most appropriate and cost-effective packaging.

From the primary packaging to the final packaging, UniD can support you during clinical trials manufacturing but also during commercial production:

  • Primary and secondary packaging materials selection (soft pouch, blister)
  • Early-stage integration of packaging activity to assess potential impact of irradiation on the product
  • Versatile in-house packaging dedicated area to support standard and atypical demands

 

Packaging