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Regulatory Affairs Department

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Technology Transfer


Our services cover ALL the key phases of a technology transfer (see below for details):

1. Regulatory Affairs

2. Validations

3. GMP Certifcation

4. Training

5. User Requirement Specs 

1. Regulatory Affairs

We offer professional support, as specialized & complete as possible, adapted to the new regulatory demands and requirements of all Health Authorities. The goal is to obtain marketing and market placement authorizations fast. 

We have managed dossiers from top pharma companies worldwide such as Pfizer, Sandoz, Ratiopharm.and Stada.

Our expertise allow us to develop all the necessary tech transfer regulatory documents from Manufacturing Master Purchase specifications of raw materials and raw material Quality Control methodology to secondary packing materials specifications or Operative SOP (Standard Operation Procedures), manufacture and QC.

2. Validations

  • Quality control laboratory: analytical test method validation, computer system validation, qualification of analytical equipment.
  • Equipment commissioning/qualification: manufacturing, packaging, laboratory, facilities/utilities.
  • System validation for GMP applications.
  • Computerized system validation life cycle.
  • Validation package assessments.
  • Statistical support (SPC, DOE, data analysis, sampling assessment).

3. GMP Certification

  • Processes & procedures (SOP’s)
  • Qualification: equipments, areas, etc
  • Audits

4. Training 

  • Analysis and definition of training requirements
  • Job description & specification
  • Selection of personnel
  • Analysis of curriculum vitae
  • Initial training
  • Appointment
  • Annual Training Program & certification

5. User Required Specs

  • Objectives
  • Legal & regulatory framework
  • Project Definition
  • Qualification and validation documentation
  • Terms and restrictions