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Pharmaceutical Development

From pre-formulation to market-ready medicine. We support drug development at every stage: formulation, analytics, scale-up, clinical batches and registration, on the site that manufactures it.
Services
Pharmaceutical Development
From pre-formulation to market-ready medicine. We support drug development at every stage: formulation, analytics, scale-up, clinical batches and registration, on the site that manufactures it.

Pharmaceutical Development: From API to commercial-ready product

We at NextPharma provide integrated pharmaceutical development across a connected European network of specialist sites. Formulation development, clinical batch manufacture, scale-up and technology transfer are managed within the same organisation – from first feasibility through to validated commercial supply. If you are evaluating a development partner who can carry your programme from pre-formulation to commercial scale without a change of organisation, you are in the right place. See how development connects to our commercial manufacturing capabilities.

The development pathway

01

Pre-formulation and formulation development

Development begins with feasibility assessment and dosage form selection, covering API characterisation,
technology screening and formulation strategy. We define the quality target product profile, assess risk, and build
formulation and process development around scale-up requirements from the outset. Analytical method
development, packaging compatibility studies and stability testing to ICH requirements are integrated throughout.
The objective is a robust formulation concept that transitions directly into clinical manufacturing without redesign.
Pharmaceutical development

02

Clinical batch manufacture

Once the formulation is defined, clinical batches are manufactured under GMP to support Phase I through Phase IV
studies. Our integrated model brings together GMP batch manufacture and Clinical Trial Services within the same
network — covering QP release, phase-appropriate analytical method validation, release testing and direct
translation of prototype formulations into clinical material. Sponsors benefit from a seamless handover between
clinical manufacturing and clinical trial services, with no change of partner, no gap in the quality chain, and a single
project manager coordinating throughout.

03

Scale-up and market readiness

Scale-up is led by the same technical teams that developed the formulation, preserving process understanding end-
to-end and eliminating the knowledge loss inherent in external transfers. Activities include analytical method and
process validation, manufacture of validation batches, ICH-compliant stability studies and full readiness for
commercial manufacturing and launch.

04

Product optimisation and technology transfer

Transferring a product to a new manufacturing site is one of the highest-risk steps in a product’s lifecycle. We at
NextPharma have built a structured transfer methodology that minimises disruption, protects your regulatory
timeline and gets your product into routine production as quickly as possible. We handle inbound transfers from
other CDMOs, from in-house pharma sites and from development organisations moving a product into commercial
manufacture for the first time.
Pharmaceutical Development

What our tech transfer covers

  • Technical gap assessment – review of existing batch records, process parameters, analytical methods and equipment compatibility

  • Analytical method transfer and validation – full transfer of release and stability methods to our in-house QC laboratories, including comparability studies where required

  • Process adaptation and scale-up – translation of the existing process to our manufacturing platform, with documented process development runs where needed

  • Regulatory documentation support – CMC data for variation filings, site change supplements or new MAA submissions across EU, US and other global markets

  • Engineering and PPQ batches – through to process performance qualification and formal site transfer completion

Specialist development capabilities

Our development network is structured around specialist technologies, regulated product categories and complex dosage forms – each integrated with the corresponding commercial manufacturing site.

Softgels and lipid-based formulations
Soft capsules and liquid-filled hard capsules, supporting bioavailability enhancement, solubility enhancement, mitigating food effect, improved stability and complex APIs
Sterile ophthalmics
Ophthalmic solutions including preservative-free systems, BFS single-dose and multi-dose formats at a dedicated sterile site
Oral paediatric formulations
Mini-tablets, taste-masked formulations and adapted dosage forms for paediatric use
Topical and semi-solid dosage forms
Creams, gels, ointments and suppositories including standard and hormonal formulations
Oral modified-release technologies
Pellet-based systems, coating technologies and controlled-release formulations for API release management and protection
High-potency / containment (HPAPI)
Dedicated containment capabilities across development and manufacturing sites
Controlled substances
Licensed handling and secure development and manufacturing
Antibiotics
Segregated capabilities for antibiotic handling to avoid cross-contamination

Development network and site capabilities

Development activities are supported by specialist centres of excellence across Europe, each aligned to specific technologies and dosage forms.

Berlin

Projects can be fully managed from a single site, combining formulation, process and analytical development in one place. When a project benefits from capabilities across several sites, we coordinate through a single project manager, with cross-site teams pooling formulation, analytical and manufacturing expertise and direct transfer of knowledge and processesbetween sites.
Explore our full manufacturing network

From development to commercial manufacturing – no handoff risk

A defining feature of the NextPharma development model is the direct link between development and commercial manufacturing within the same network. Formulations are developed with scale-up in mind from the start. Manufacturing processes are designed for internal transfer to commercial production. Knowledge and process understanding are retained within the same organisation across all stages.

Compared to multi-partner models, this reduces technical and regulatory risk and supports faster progression to commercial supply — without the complexity of transferring programmes between organisations. Clients benefit from accumulated product knowledge, preserved process understanding and a seamless scale-up path from first batch to routine commercial production.

Commercial Manufacturing & Packaging
Pharmaceutical Development
  • HPAPI Containment
  • Tech Transfer
Clinical Trials Services
Analytical & Microbiological Services
Health & Nutrition
Get in touch
Discuss your Pharmaceutical Development programme
Share your API, dosage form strategy and clinical or commercial timelines with our development team. We will confirm technical fit, outline the development pathway and identify the relevant specialist sites for your programme.

Get in touch with NextPharma

Whether it's development, manufacturing or supply. Tell us about your project and our experts will get back to you.