Quality partner to your business development

Complete solutions for all challenges of pharmaceutical regulations requirements

QUALITY

Quality systems

We provide services for new and existing companies in quality system creation and upgrade (GMP / GDP environment)

Audit services

Outsource your external partner inspection or prepare for scheduled regulatory audit (GMP / GDP environment)

Consulting

Forward all inquiries and challenges from your daily operations and we will provide individual problem-solving approach with solutions based on previous experiences

Based on years of internal experience and network of freelance specialist we can provide complete service tailored to your requirement within GMP / GDP quality systems including but not limited to:

  • Creation and implementation of GMP / GDP systems
  • Upgrade of existing quality system or implementation of new regulatory requirements
  • Creation and implementation of individual quality system documents based on your requirements (SOP, URS, qualification and validation documentation, etc.)
  • Cooperation and support in selection of partner for outsourced activities including audits

All performed activities will be completely customized to your existing quality environment. Upon completion of activities, we will provide education and transfer all the relevant information / skillset to your employees in order to endure full system integration. Upon completion of activities, we will provide education and transfer all the relevant information / skillset to your employees in order to endure full system integration.

Regulatory Affairs

Z

Preparation (CTD format) and submission of regulatory documentation

Post registration support – regulatory compliance management

Consultation on regulatory requirements for your medical device

We can provide services for all your regulatory requirements from pre-authorization strategy, conduct submission of Marketing Authorisation Applications and support you during post-approval and submission. Please feel free to contact us for advice regarding any challenges in your products lifecycle.

Our services include but are not limited to:

  • Submission of Marketing Authorisation Applications to regulatory authority
  • Communications with relevant regulatory authority regarding your needs
  • Creation of regulatory dossier in eCTD format
  • Submission, and management of applications, renewals and notifications
  • Transfer of Marketing Authorization Holder
  • Translation and preparation of SmPC, PIL and Labelling in accordance with legislation for Croatian and other languages
  • Preparation of mock-ups and proofreading

MEDICAL DEVICES

Quality system: Support and preparation of needed documentation system for medical devices wholesales operations

Z

Registration application for medical device

Consultation on regulatory requirements for your medical device

Medisint offers full range of services for all your needs regarding production, distribution and registration of medical products.

We are aware that constant increase in regulatory requirements for medical product can present challenges for your business and that is why we have prepared solutions for optimizations of your projects that include medical devices.

Our services include but are not limited to:

  • Preparation and submission of documentation required for registration of medical devices
  • Support and creation of quality system required for medical devices wholesales operation
  • Submission of required documentation for medical device wholesales operations database

WHY CHOOSE OUR SERVICES

CONFIDENTIALITY

All communications and outsourced activities are cover with confidentiality and non-disclosure agreement.

INNOVATIVE APPROACH

We employ network of freelance specialist to ensure that your request will be handled by most experienced person.

0

FLEXIBILITY

We can provide as little information or as complete service as you request for each inquiry.