AqVida Oncology - High Barrier to Entry Oncology Generics and Biosimilars

The main focus of AqVida Oncology lies with the development and manufacturing of innovative products, particularly high barrier to entry oncology generics and biosimilars.

The main focus of AqVida Oncology lies with the development and manufacturing of innovative products, particularly high barrier to entry oncology generics and biosimilars. AqVida oncology is always looking to expand its portfolio by developing new formulations or licensing, always in strict adherence to high European Quality standards.

Our expert scientists compile dossiers in CTD format and DMFs for regulated and less regulated markets, and our experienced multinational regulatory affairs team provides the highest degrees of competence. They also have direct contacts to regulatory authorities in various countries and a strong track record of completed registration procedures.

AqVida applies a quality management system that adheres to German legal requirements for the pharmaceutical industry (i.e. AMG and AMWHV). We have a strict quality system in Germany, assuring that all suppliers are compliant with EU-GMP regulations by inspecting their sites by ourselves and together with European authorities.

Our spectrum of services does not stop at the development and manufacturing of innovative drugs - we also work as consultants by providing a complete service for the successfully launch of new products within a short period of time with efficient allocation of resources. This implies familiarity with the markets and knowledge about the industry as well as the country- and product specific regulatory.

Furthermore, we offer raw materials of high quality from our cooperation partners. We provide all the necessary documentation and technical understanding to fulfil the requirements of registering products in your country. A full list of our APIs can be found here.

History

AqVida was founded in 2003 and we started our own developments with Filgrastim in 2005. The first registration of a finished formulation was launched 2006 in Mexico with Neuropad and Becaplermin. Subsequently, we started registrations in more regulated markets like Russia with Tamsulosin and Filgrastim in 2008 and Europe with Oxaliplatin and Vinorelbine in 2009. In 2008 AqVida received the status as a pharmaceutical company from the German health authorities.

A couple of strong cooperation partners in the respective countries enable the company to diversify its operations in well regulated markets with slower growth rates as well as less regulated and emerging markets with high growth rates.

Our philosophy

AqVida follows some core principles which we believe are crucial factors for the success of a company, and even more so in the pharmaceutical industry. Compliance with GMP standards and documentation of high quality are a must, whilst safety, health or environmental issues are taken as a matter of course.

• Be reliable - agreements need to be stuck to, promises must be kept. This and this alone makes for a reliable business partnership. Our aim is to develop long-term, mutually beneficial relationships with our clients
• Be transparent - without transparency there can be no trust: this applies to both commercial and quality issues. We aim to be fully transparent in our quality assurance process by inviting partners to come and learn about our quality assurance systems, and we ensure that, commercially, all of our profits are shared in a fair and transparent way
• Be quick - speed is paramount in the pharmaceuticals industry; therefore we always aim to execute our services and solutions as quickly as possible
• Be diverse - every astute company knows that there is strength in diversity, and we welcome a variety of different people to their different strengths and skills to the best possible effect
• Be creative - the pharmaceutical industry is dynamic. Therefore, we use creative solutions to adapt to ever changing market requirements and situations

We believe that adhering to the described principles results in services of highest quality and efficiency.

Contact details

AqVida GmbH
Kaiser Wilhelm Str 89
D-20355
Hamburg
Germany

Phone: +49 40 380371 90
Fax: +49 40 38071 92

Web: www.aqvida.com