The analytical development department of Zinereo Pharma provides services for the development and validation of analytical methods according to the ICH guidelines in the following stages:
- Project plan agreed with the client.
- Search for information.
- Method test.
- Preparation of validation protocols.
- Execution of the validation protocols and final report.
We provide services for the development and evaluation of dosage forms, which includes the following activities:
- Preformulation studies and selection of dosage form.
- Compatibility studies of active ingredients and excipients.
- Formulation studies and design of the manufacturing method.
- Implementation of necessary in-process controls.
- Preparation of development batches for forced stability studies and product compatibility with packaging material.
- Manufacturing of registration batches including Industrial scaling.
- Validation of the industrial process.
- Preparation of experts’ reports.
- Preparation of product dossier.
All the development studies are carried out in accordance with our GMP certification.
The manufacturing of pilot and industrial batches for registration purposes is conducted in our own facilities or third-party facilities always in accordance with the GMP system.
SHORT AND LONG-TERM PHYSICAL AND CHEMICAL STABILITY UNDER THE ICH GUIDELINES
We have ICH-approved climatic chambers (25ºC/60%RH; 30ºC/65%RH, 30ºC/75 and 40ºC/75%RH) guaranteeing that all the necessary humidity and temperature parameters are being monitored at all times. They all have an electronic system to record humidity and temperature values.
This makes it possible to conduct stability studies of dosage forms for the purpose of obtaining documentary evidence on how physical, physical-chemical, microbiological and biological characteristics vary over time under the influence of environmental factors such as humidity, light and temperature, as well to establish storage conditions and expiration dates.
We provide manufacturing services for third parties covered by our Authorization as Medicine Manufacturers and our GMP Certification.
The company is currently authorized to manufacture the following dosage forms:
- Manufacturing of hard capsules.
- Manufacturing of tablets and film-coated tablets.
- Manufacturing of other dosage forms (powders and granules).
- Manufacturing of liquids for internal use.
- Manufacturing of liquids for external use.
- Primary packaging of the aforementioned dosage forms.
- Blister packs: In different aluminum combinations and duplex or triplex combinations of complex plastics.
- Single-dose packages (blister packs and strip packs).
- Stick packs.
- Glass bottles, PET, HDPE, etc.
- Tablet packaging in controlled relative humidity.
- In-line printing of the aluminum film.
- Secondary packaging.
- Flexibility for manual packaging.
- Authorization for the manufacturing of investigational medicinal products in all the aforementioned dosage forms.
We are specialized in supplying the Spanish market with all sorts of healthcare and pharmaceutical products.
Our storage and distribution facilities, which extend over 3,000 m² and whose controlled temperature ranges between 15-25ºC and 2-8ºC, have been authorized as a Distributor and have received the Good Distribution Practices Certification.
Our staff is highly capable of adapting to the demand of laboratories and clients.
We provide the following services:
- Receipt and sampling.
- Storage and stock management for our clients.
- Order processing in less than 24h.
- Efficient transport management for each case, with the main companies of this industry. Order delivery in 24-48h.
- Returns processing (reverse logistics) and destruction of products.