BioTop Medical

Business focus: BioTop Medical has a main focus on applying regulations with impact on the (pre)marketing of medical devices and pharmaceuticals and supporting post market trajects with regard to Regulatory Affairs and Quality Management.

BioTop Medical
Rijnsburgerweg 10
2333 AA Leiden
Website BioTop Medical
E-mail BioTop Medical
T +31 (0)71 528 01 12
F +31 (0)71 528 01 15

Employees in Amsterdam: 0
Employees in R&D: 0
Year of foundation: 2002

Company Profile

BioTop Medical provides expert knowledge and supports pharmaceutical and medical device industry (including in vitro diagnostics) on Regulatory Affairs (RA) and Quality Management (QA) requirements regarding the development and registration of medical products. We are a team of Life Scientists who combine their scientific knowledge with experience in Regulations and Quality Management systems.
We are dedicated to medical companies: working hands-on from the first idea to market introduction of the product and further (Post Marketing Surveillance, vigilance, etc).
Our core business is the application of (mostly EU, USA, Canada) regulations with impact on the marketing approval of medical products. Areas of expertise include:

Pharmaceuticals
Medical Devices
Quality Management Systems (GMP & EN-ISO 13485)
Medical Writing

Science and Technologies or Services

Our services range from being a source of expertise to acting as your Regulatory Affairs or Quality Manager:

Coordinate & prepare the Marketing Authorization Application of pharmaceuticals: compilation and maintaining of (parts of) the CTD dossier;
Coordinate & prepare the files for the CE-marking (93/42/EEC & 98/79/EC), FDA & Health Canada approval of medical devices: standards, risk analysis, labeling, contact with the Notified Bodies and (competent) authorities;
Set-up, update, implement and audit the quality system: process identification, writing and revision of quality documents, training, internal audits and contact with the certifying authorities;
Audit product suppliers and contact manufacturers in the Netherlands and abroad;
Writing of medical documents such as clinical study reports, leaflets and summary documents;
Supporting the Qualified person (QP) with Quality Assurance, internal or supplier audits, quality related software audit and Gap Analysis of quality related automated systems.