Professional advice and support – we support your pharmaceutical development.
After successful completion of the preclinical phase, we guarantee you expert and professional advice and support in the pharmaceutical product development of your drug candidate.
Product development for pharmaceuticals
After successful completion of the preclinical phase, we guarantee you expert and professional advice and support in the pharmaceutical product development of your drug candidate.
Full service or partial developments
We offer all services for clinical trials (phases I-IV), project management, data management, medical writing and pharmacovigilance. Key steps must be considered, including design performance and safety, operational efficiency, risk management and regulatory requirements.
Step by step to the finished product
We organize these aspects of scientific support in the specially developed specifications of our ISO 9001:2015 quality management system. You can outsource the entire project or parts of the product development process to us. We create an individual strategy plan that fits your product and helps to avoid delays and pitfalls in such important projects.
Product development for medical devices
Certification procedures for medical devices are part of our daily business. Certification procedures are becoming ever more demanding and are confronted with constantly increasing requirements to prove the suitability of a potential medical device. Nevertheless, innovations should be marketable within an economically justifiable period of time.
MDR conformity
The new EU Medical Device Regulation (MDR) Regulation 2017/745 on medical devices of April 5, 2017 came into full force on May 26, 2021 with a transitional period of 4 years and after a postponement due to the COVID-19 pandemic, replacing the previously valid EU directives on medical devices and the Medical Devices Act. As regulations, unlike directives, do not require transposition into national law, they apply directly in all EU member states.
Compliance with the statutory transition periods
The MDR regulates the placing on the market, making available on the market and putting into service of medical devices intended for human use in the EU. It applies to manufacturers, authorized representatives, importers, distributors and other persons named in the MDR, among others. All stakeholders are subject to strict requirements and obligations; for example, manufacturers are obliged to set up, implement and document quality and risk management systems.
Your protection against high administrative penalties
Medical devices are classified into classes I, IIa, IIb and III, taking into account their intended purpose and the associated risks and in compliance with special classification rules. Classification is carried out in accordance with Annex VIII of the MDR. Certain obligations and legal consequences are linked to the corresponding classification. (Attempted) violations of the regulations and high requirements of the MDR can result in high administrative penalties.
To ensure that you remain competitive, we and our sister company Medicoforum GmbH (certified according to DIN EN ISO 13485:2016) will support you with the correct classification, the optimization of technical documentation and the entire certification process.
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover