Synoptis Pharma competencies:
High-class professionals responsible for the registration of our products ensure their compliance with the requirements imposed by relevant authorities: Chief Sanitary Inspector, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Chief Pharmaceutical Inspector. . Registration dossiers prepared for medicinal products, food supplements, cosmetics and medical devices are developed in accordance with applicable Polish and European laws and guidelines. Thus, the medicinal products are registered in accordance with the national as well as European procedures.
QUALITY ASSURANCE AND CONTROL (QA/QC)
We work only with the manufacturing sites which, for the sake of the highest quality and safety of their products, have in place GMP, HACCP, GHP or ISO systems depending on the status of their manufactured products We supervise and monitor manufacturing processes through qualifications/audits at our producers. We already have approx. 50 qualified suppliers/manufacturers. We test all our products before marketing. We care about the quality and safety of all the offered prod-ucts throughout their entire life.
In 2016, we accepted 1,600 batches of APTEO®, CERA PLUS Solutions and GENOPTIM® brand products. All the batches were thoroughly checked by QA/QC team. We sold 31.6 m packages, and the complaint ratio for 2016 was only 0.010%.
Research & Development Office is responsible for a reimbursement of our medicinal products. It prepares all the documentation, including requests for official pricing and for entering the products on the reimbursement lists.
Taking care for the health and safety of patients, we discharge our pharmacovigilance obligations. We follow applicable internal procedures and national as well as European laws. Our specialists collect, evaluate and draw conclusions from reports on possible adverse reactions in order to continuously moni-tor the benefits to risk ratio.
Synoptis Industrial works in a variety of business areas for internal needs of NEUCA Group as well as provides the following external services:
- manufacturing and packaging tablets and capsules,
- importing products from outside the European Union,
- laboratory batch quality control,
- marketing authorisations in the EU,
- manual repacking of products for the industries listed below:
- clinical trials.
Synoptis Industrial began operations in 2014 and is the first manufacturing company in NEUCA Group. Its mission is to offer a full portfolio of contracted production services for the pharmaceutical industry. We use the latest technology solutions in the processes of manufacturing, packaging and quality system management in order to deliver pharmaceutical products and dietary supplements that meet the stringent requirements of the European Union.
Our quality policy is based on the guidelines which may be found in the European GMP (Good Manufacturing Practice) and ICH (International Conference on Harmonisation). We follow PDCA (plan−do−check−act) philosophy which means we are an organisation based on learning and constant improvements to the quality of processes and delivered services.
CERA PLUS Solutions cosmetics were created in collaboration with renowned Polish cosmetic laboratories which guarantee a high quality of the products and compliance with the most stringent manufacturing standards. For manufacturing we use modern ingredients and proprietary formulations while maintaining affordable prices for the final consumers. The offered range includes 74 products.
In 2016, we made a strategic decision to optimise the portfolio and proceed with a specialist medical promotion. CERA PLUS Solutions is currently the brand recommended by medical doctors and pharmacists convinced of its effectiveness and quality. In the future, the offered range will principally consist of three lines – cosmetics with a high sunscreen protection, cosmetics for women with a problematic facial skin and cosmetics for dry and atopic skin (emollients).
For over 4 years now, we have been constantly working on launching subsequent Rx medicines. The offering allows pharmacists to combine their professional mission with a stable business. Meanwhile, the patients are provided with an effective and safe therapy at a price that will allow them to purchase prescriptions. GENOPTIM® brand and other Synoptis Pharma Rx drugs include 64 products in therapeutic categories which are the most popular on the market such as: cardiovascular, digestive, nervous, urological, ophthalmologic and antibiotics. We consistently expand the offered range with subsequent hospital products.
We also gradually expand the portfolio of APTEO® brand by subsequent new preparations. APTEO ® brand was created for pharmacists in response to their most important needs. Its broad portfolio includes dietary supplements, general consumption items, OTC medicinal products, medical devices, care products as well as diagnostic and dressing materials.In 2016, under five sub-lines of the brand we launched 33 new products while maintaining their high quality and attractive pricing. We worked on product quality, controlling their manufacturing for compliance with the ISO system requirements.
Number of products in 2016.
SALES OF OUR OWN PRODUCTS TO PHARMACIES