Minimizing the Expenses

We manage the necessary logistics of merging both clients experts and CMO partner experts in a mutually agreed facility that is well equiped with bleeding edge technology to carry out all processes, testing, final production and packaging. In order to achieve excellent outcome and client satisfaction,  we ensure that all dosage forms  are adjusted on case-by-case basis (e.g. by using risk management principles in accordance with technical agreement in place.

Formulation and production technology transfer programmes 

  • We engage in non formal meetings to initiate a discussion aimed at understanding client needs  and strategic interest.
  • Once needs and strategy is determined we formalise our discussion to initiate planning phase in connection with intended product pipeline.
  • A well thought out plan advances to execution phase where we let the scientists do their trick, while we monitor their progress document and report to sponsor.
  • At the end of project, an evaluation of success is communicated to sponsor who verifies final deliverable.
  • A successful project conclusion is the end result expected by all parties involved, to achieve a Win Win situation. 


Why Choose Us?

  • You get to choose your desired location by proximity.
  • you get to choose adequate facility from provided options.
  • You get to choose facility based on available bleeding edge technology. 
  • you get to independently control price and speed 
  • Your risk is ours to bare

Process Transfer

We facilitate the provision of process tranfer in a standardized documentation format in collaboration with both donor experts and recepto experts. Our goal is to realise and harmonise in use processes and new improved processes to comply with regulatory requirements in terms of Efficacy, Quality and Safety.

Our services include: Change control, Process Flow, URS, FDS, IOQ, PQ, Cleaning validation, PV, Training, SOP’s

Scope of Transfer Process includes:
  • Safety assessment
  • Quality assessment 
  • Financial assessment 
  • Overall Timeline 
  • Framework for Technical Transfer Plan 
  • Definition of project boundaries –What is in scope, what is out of scope
  • Identification of Risks and Opportunities

Technology Transfer

We provide experts and collaborate with our partner contract manufacturing organisations to train, provide well documented  technological know how, to ensure that scientific and technological developments are accessible to our clients who can then further develop and exploit the acquired knowledge into new products.

Our consultation services includes the following:

  • Safety assessment managenent
  • Mapping of production process with SME / Operators
  • Identification of Critical Process Parameters (CPP) and Critical 
  • Quality Attributes (CQA) as they relate to finished product
  • Confirmation of all CPP / CQA have studies to support acceptance
  • Conducting studies to confirm CPP / CQA ranges to close identified gaps
  • Determination of best practice / gold standard process
  • Creation of CPP / CQA database
  • Comparison of CPP / CQA data values to “gold standard” and ranges to enable educated process adjustment.

For more information please contact us to schedule technical discussion with our experts  click here.

Our experts and partners specialise in implementation of logical procedure that controls processes documentation and implementation.

we manage the following:  

  • Transfer of development and production (processing, packaging and cleaning)
  • Transfer of analytical methods for quality assurance and quality control
  • Skills assessment and training
  • Organization and management of the transfer
  • Assessment of premises and equipment
  • Documentation; qualification and validation

Protocol

  • Protocol defining the steps for transfer of analytical methods that includes:
  • Objective, scope and responsibilities of the SU and the RU
  • Specifications of materials and methods
  • Experimental design and acceptance criteria
  • Reference samples (starting materials, intermediates and finished products)
  • Documentation (incl. information to be supplied with the results, and report form; deviations; references and approval)

Methods

  • Recording of number of times the procedures have been performed
  • The largest batch size produced
  • Analytical methods used 
  • The level to which the analytical methods have been developed
  • Samples of intermediate steps
  • Sequence of operations for the process
  • Rationale for each process unit operation
  • Initial operating ranges for process parameters
  • In-process controls
  • Initial acceptance criteria for the product
  • Development batch records
  • Process and analytical development reports
  • Assay qualification reportsx
  • Test methods
  • Guidance on process ranges
  • Operating parameters as well as initial specifications
  • Qualified reference standards
  • Markers for impurities and process intermediates


For more information please contact us to schedule technical discussion with our experts  click here.