Unither Developpement Bordeaux logo

Your Innovation &

Development partner

Our know-how

r&d
Pharmaceutical development
  • Formulation
  • Pre-clinical
  • Clinical
development icon
Small batches manufacture 
  • Clinical
  • Commercial
  • Consumer/ market tests
Promise
Analytical services

Ad hoc and/or part of a pharmaceutical development

Values-1
Regulatory support

Development strategy & compiling IMPD

 

Product forms

(sterile / non sterile)

1-1
2-1
3-2

Solids

Powders, granules, tablets, capsules

Liquids

Solutions, suspensions, syrups, (nano)emulsions

Semi-solids

Gels, creams, ointments, suppositories, pessaries

 

Our technologies

UDBshortpresentationv1 EA-1

Development of ophthalmic products

NCE, repositioned molecules, hybrids/generics + etc.

Solution, suspension, gel, emulsion formulation and analytical development

MULTIDOSE with and without preservatives
MicrosoftTeams-image (64)

 

Orphan drugs & Rare diseases

Development / production 

 

Pharmaceutical development

One-stop shop approach for a faster time to market

Molecules - adapted environment
Services
markets

 

Analytical services

  • Analytical development
  • Pharmaceutical development support
  • Analytical reverse engineering (formulation support)
  • Validation, co-validation, transfer
  • Cleaning verification
  • Quality control
  • ICH / VICH stability studies and preliminary stability studies

02-2020_08_18_DEV00000510-WWW.BLACKBOXSTUDIO.FR-7
ich vich stability studies
analytical dev. / quality control
validation / covalidation / transfer
cleaning verification / pharma dev. support

Production services

Innovative mechanism-1

Manufacturing expertise services

  • Manufacturing process development and optimization
  • Life cycle management such as clean label/reformulation, new packaging testing
  • Pilot and technical batches
  • Scale-up & industrial transfer
  • Trouble shooting: new regulation compliance, stability remediation, manufacturing process improvement
technical support

Product supply 

Development area
  • Prototypes
  • Pre-clinical supplies
GMP batches manufacturing

  • Clinical batches manufacturing (& placebo): Phase I to III

  • Small commercial batches (niche) manufacturing

  • Consumer/market tests

Regulatory support

Development strategy

Compiling IMPD

Pre and post-marketing: clinical study authorization requests (IND, IMPD), registration files (NDA, CTD, safety report, etc.)

40

Any project? Development or Analytical support?

Contact us!

Fill out this form and we will reach out to you to propose you the best support solutions. Contact us!

IMG_4080