We are an European Contract Research Organization (CRO) offering services for vigilance of products, services of Qualified Person and Responsible person for handling, storage and distribution of medicinal products and regulatory affairs consulting services worldwide. We are experts in CMC writing and in setting regulatory strategies as well as in finding best possible regulatory and sales solutions. Our company is represented by a team of experienced regulatory affairs consultants, scientists, HR managers, Qualified person and sales managers with in-depth knowledge of international Regulatory requirements, Quality Assurance and Control, Analytical and Organic Chemistry, Biochemistry and Genetics, Business relations, HR management, Sourcing and Sales services covering worldwide markets.
Currently we are establishing business cooperation with global Pharmaceutical and Biopharmaceutical companies, Centres of Excellence and National Research Institutes.
Read More... →
Quantum Chimica is a trust-worthy partner that can help you set regulatory strategies, quality and research activities as well as organize sales on international markets.
Read More... →
Read up to date news from our scope of operations as well as from the current trends in Pharmaceutical and Biopharmaceutical industry.
Read More... →
If you have any questions or suggestions do not hesitate to leave us the reply on our Question and Answer wall and we will reply as soon as possible.
Read More... →
Quantum Chimica is a trust-worthy partner that can help you prepare quality registration documentation, help you set regulatory strategies, quality and research activities as well as organize sales and marketing operations on local (EU) and international markets. Business cooperation
Why choose us?
- We are experts in CMC writing
- We have many years of experience in Pharmaceutical and Biopharmaceutical Industry, HR management and Sourcing
- We can help you prepare quality regulatory documentation (DMF, ANDA, prescription drugs, OTC, etc.)
- We can help you prepare quality regulatory documentation for medical devices, food supplements and cosmetics
- We can help you set Pharmacovigilance system
- We can help you set Quality System
- We can act as Qualified Person for Quality and Pharmacovigilance, and as Responsible person for handling, storage and distribution of medicinal products on your behalf at local Ministries of Health
- We can help you set change control management system and organize storage of your products (ambient and cold chain temperature)
- We guide you efficiently through registration procedure to reach Marketing Authorization
- We can help you enter into local (EU) and international Pharmaceutical and Biopharmaceutical markets
- We have good connections with local and international Research Institutes, Pharmaceutical and Biopharmaceutical companies and international CRO companies
- We provide quality, efficient and fast regulatory solutions
- We offer ongoing support and competitive prices for all services in regulatory affairs consulting
-
AIDS Vaccine Could Work Against Changeable HIV Sites
A vaccine or other therapy directed at a single site on a surface protein of HIV could in principle neutralize nearly all strains of the virus—thanks to the diversity of targets the site presents to the human immune system. The finding, from a study led by scientists […]...
Read more →
-
Researchers Discover Novel Molecule to Treat Asthma
A new study carried out by researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham), the Max Planck Institute for Colloids and Interfaces (Germany), the Free University of Berlin (Germany), UC San Diego, and Shinshu University (Japan) has identified a novel molecule that prevents T-cells from orchestrating asthma brought […]...
Read more →
-
Regulatory Affairs Manager – a key expert within the Bio/Pharmaceutical industry. How to become one?
Quantum Chimica Ltd. is organizing a live webinar that will take place on January 26, 2016 and will cover the insights of Regulatory Affairs Manager´s knowledge requirements, benefits and responsibilities in about 60 minutes with the title: Regulatory Affairs Manager – a key expert within the Bio/Pharmaceutical […]...
Read more →
-
FDA publishes Purple Book
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological […]...
Read more →
