Kahlity We are a team of dynamic consultants with a proven track record for managing projects and providing consulting services to companies within the medical devices and pharmaceutical industries

Regulatory Affairs

Technical documentation

 

Our consultants help you to build a complete technical file in compliance with applicable requirements.

We perform legacy review and remediation activities to bring back your technical documentation into compliance.

 

Who would be interested by this service?

All Legal Manufacturers of new or existing medical devices

Product registration

We help you to register your products in multiple markets.

Our partner developed the most successful product registration software in compliance with regulations of more than 140 countries.

 

Who would be interested by this service?

All Legal Manufacturers willing to select specific markets (e.g. Swiss and European markets) or expand their markets worldwide.

 

Regulatory strategy

We help you to define the most suitable regulatory strategies for your company. For example, we help you to remove or add products to your product portfolio depending on sales volume and costs. We also help you to remain in compliance when regulatory requirements are open to interpretation. We help you to define your market expansion strategy with the support of marketing and regulatory experts.

 

Who would be interested by this service?

All Legal Manufacturers willing to grow their business.

 

PRRC

We have consultants who can be your Person Responsible for Regulatory Compliance (PRRC) as described in the Article 15 of the MDR. 

We are permanently and continuously at your disposal.

 

Who would be interested by this service?

Small Legal Manufacturers who employs less than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million, as defined by the Commission Recommendation 2003/361/EC Swiss Authorized Representatives, European Authorized Representatives