Product Authorisation and Maintenance

It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and their extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.

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Medical devices approval

Given the complex nature of the medical device industry, an effective QMS must be more technically driven and requires extensive documentation. CE mark for medical devices confirms compliance with essential regulations for entry into European countries.

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Pharmacovogilance services

The ultimate goal of pharmacovigilance is to appropriately handle information concerning adverse drug reactions and to protect the public from emerging safety issues throughout a medicine’s lifecycle.

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QP & batch Release services

QP certification is a mandatory step, ensuring the batch meets GMP and regulatory standards. The use of a Qualified Person (QP) to review and confirm compliance of each and every GMP batch for clinical and commercial use is a regulatory requirement when releasing your product into European markets.

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ABOUT US

Based in Amsterdam, The Netherlands and Bucharest, Romania RegPak BioPharma Consulting is a full service Consultancy with the key objective of providing high quality services within Regulatory Affairs, Technical Services, Pharmacovigilance and QP & QC services to the BioPharma industries.

PARMINDER KAUR

Founder and Consultant

Our pioneering spirit enabled RegPak BioPharma Consulting to drive forward bringing positive outcomes in the projects. We rely on integrity and trust-building throughout the organization.

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