Let's help your pharmaceutical needs
We offer sterile Medicine in vials development, registration documentation preparation, contract production, including packaging and serialization.
Contract production
We will produce sterile medicine and Experimental Series (IMP) products tailored to your needs, with a capacity of up to 1 million sterile vials per year.
Product licensing
Begin producing and selling ready-made dosage forms without investing in product and technology development
Extractions with SCF technology
Efficient and rapid extraction of natural substances and products using CO2. We are the only company in Latvia that can perform extraction using supercritical fluid (SCF) technology.
Contract development
From the development and testing of dosage forms to the registration of a license and the comprehensive technical documentation (CTD).
Serialization
The production of sterile products is carried out using batch technology and in accordance with the Good Manufacturing Practice requirements of the European Union, including serialization and aggregation
Quality
” Good Manufacturing Practice " (GMP) certificate
We are a certified "Good Manufacturing Practice" company that has also been evaluated many times by more than 14 countries around the world, including South Korea, Canada, Russia, United Arab Emirates, Turkey, Taiwan.
Quality control
Our quality assurance and quality control teams perform quality tests both in product raw material and between and end products in accordance with ICH guidelines.
High level equipment
To ensure quality at every step, we use high-end innovative equipment and processes, such as SCF extraction unit, UV/VIS spectrophotometer, high-performance liquid chromatography (HPLC) units.
Contract production
Your product in our factory.
Manufacture of sterile medicines
According to your specific needs, our production capacity reaches up to 1 million sterile vials per year.
Quality
According to your needs, we will produce experimental series Injection preparations (including chemotherapeutic) for Phase I – III clinical trials.We also provide marking, packaging and delivery of Experimental Series according to the relevant regulations.
| Production technology | Main production steps | Vial size | Production batch size | |
|---|---|---|---|---|
| Cytotoxic products | Non-cytotoxic products | |||
| Freeze-drying | Preparation of intermediate product | 8 ml | up to 1550 | up to 6550 |
| Sterilizing filtration of solution | 10 ml | up to 1550 | up to 5470 | |
| Vials aseptic filling | 30 ml | up to 490 | up to 3430 | |
| Freeze-drying | Depends on freeze-dryer capacity (2) | Depends on freeze-dryer capacity (2) | ||
| Vials aseptic stoppering and sealing | ||||
| Aseptic filling | Preparation of intermediate product | 2 ml | Up to 20 L solution volume (3) | Up to 350 L solution volume (3) |
| Sterilizing filtration of solution | 6 ml | |||
| Vials aseptic filling | 8 ml | |||
| Vials aseptic stoppering and sealing | 10 ml | |||
| 30 ml | ||||
| Terminal sterilisation | Preparation of intermediate product | 2 ml | Up to 20 L solution volume (3) | Up to 350 L solution volume (3) |
| Sterilizing filtration of solution | 6 ml | |||
| Vials aseptic filling | 8 ml | |||
| Vials aseptic stoppering and sealing | 10 ml | |||
| Terminal sterilisation by steam | 30 ml |
(1) Any other size of vials in range 1-100 ml may be considered
(2) Batch size for other vials size may be requested separately
(3) More detailed calculation can be done, knowing the specific size of vials and fill volume
Contract development
Your idea – our experience for the full development process
Development of ready-made dosage forms
We offer contract production of sterile products in vials according to your developed documentation, as well as we can carry out technology development. Pharmidea provides production of 3 types of sterile products:
Sterile filling ( under laminar flow)
Filling vials with final thermal sterilization (autoclaving)
Freeze-drying of filled vials
Technology transfer and registration of developed dosage forms
Transfer and receipt of production technology from a third-party representativem.
Development, testing and transfer of analytical and microbiological methods based on the requirements of ICH, European Pharmacopoeia and Russian Pharmacopoeia.
Preparation of general technical documentation (CTD) for registration of developed products in EU countries.
Stability studies
We carry out Accelerated, Intermediate and long-term stability studies according to ICH guidelines.
We ensure the process of transfer of analytical and microbiological methods of stability research between laboratories according to the requirements of ICH, European Pharmacopoeia and Russian Pharmacopoeia.
Development of an experimental series (IMP) for clinical trials
We carry out Accelerated, Intermediate and long-term stability studies according to ICH guidelines.
We ensure the process of transfer of analytical and microbiological methods of stability research between laboratories according to the requirements of ICH, European Pharmacopoeia and Russian Pharmacopoeia.
Development of an experimental series (IMP) for clinical trials
Improvement of Experimental Series drug formulas for Phase I-III studies.
Creation of production technologies for laboratory and also large-scale production conditions for experimental series of drugs.
Preparation of general technical documentation (CTD) for Experimental Series products.
Product licensing
Produce and sell ready-made dosage forms.
Start sales without product development
We offer to advertise our products to professional pharmaceutical companies all over the world. After obtaining the product license, we will support the registration of products and will be happy to be your contract manufacturer for the licensed product. Pharmidea has very extensive experience in product licensing and registration all over the world and we are happy to expand our range of customers and products.
Serialization
Provide products with appropriate labeling
Full range of services
- Generating serialization numbers and assigning Data Matrix Code in GTIN/NTIN / PPN formats.
- Printing the serialization code on cardboard packaging:
- Packing-35x15x50mm to 120x100x180mm
- Printing height-25.4 mm (2D-code max. 12.7 mm)
- ” Proof of integrity ” stickers on each product box.
- Serialization and aggregation of packaging, transport box and pallet.
- Data exchange – both standard (XML) and custom messages and protocols.
Learn more about services and cooperation opportunities
Partners
Latvijas Organiskās sintēzes institūts
Together with PharmIdea easm, we have implemented three EU projects and are working together on a fourth
Latvijas Universiāte
AS “Grindex”
Igaunijas Vēža izpētes kompetences centrs
Rīgas Tehniskā Universitāte
AS “Olainfarm”