Technology Tranfer

Abstract :

Technology Tranfer

Padideh Technology Development Center has intra-organizational and extra-organizational connections with the country's scientific and research companies and has related product portfolios and technical knowledge. These services include the following:

🌿 Technology Transfer Process for Herbal Medicine or Dietary Supplement:

1. Lab-Scale Development:

Initial formulation design, evaluating ingredient compatibility and efficacy.
Extraction of active compounds (for herbal drugs) using methods like solvent extraction or supercritical CO₂.
Basic stability studies under stress conditions (temperature, light, humidity).
Preliminary safety/toxicity assessments (in vitro or in vivo).

2. Process Design:

Definition of manufacturing steps: extraction, drying, granulation, tableting, or syrup formulation.
Selection of equipment and processing technology.
Preparation of Process Flow Diagram (PFD) and Standard Operating Procedures (SOPs).

3. Pilot-Scale Production:

Batch production at 5–10% of full scale.
Evaluation of process scalability and consistency.
Optimization of parameters and equipment settings.
Full quality control (QC) testing of pilot batch.

4. Technical & Regulatory Documentation:

Development of a Product Dossier, including:
Final formulation
Manufacturing process
Specifications for raw materials and finished product
Safety and efficacy data (if needed)
Compilation of GMP documentation, SOPs, QC and QA protocols.

5. Industrial Batch Production:

Installation and commissioning of production line.
Production of GMP-compliant industrial batch.
In-depth QC and stability testing.
Process and equipment validation.

6. Regulatory Approvals:

For dietary supplements: license from the Food and Drug Administration (or equivalent).
For herbal medicines: registration as a drug (clinical studies may be required).
GMP certification for the manufacturing site.

7. Packaging & Market Preparation:

Design of compliant packaging and labeling.
Preparation of product leaflet, consumer information, and marketing materials.
Planning for sales and distribution channels.

8. Post-Market Surveillance:

Ongoing quality monitoring in the market.
Collection of consumer feedback and adverse events.
Possible reformulation or manufacturing adjustments based on real-world data.

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