RegPakBioPharmaConsulting

RegPakBioPharmaConsulting

Product Authorisation / 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.

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.

Pharmacovogilance

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.

QP & batch Release

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.

RegPakBioPharmaConsulting

Aristotelesstraat 18, 1064 LD, Amsterdam

Street Victor Brauner no. 400, Bl. 1, Ap. 13, District 3, Bucharest, Romania

+31 (0) 629075858

info@regpakbiopharma.com

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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

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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WHAT MAKES US SPECIAL

GLOBAL EXPERIENCE since 2008

Thorough knowledge and understanding of global relevant directives and guidelines

BEST INDUSTRY
EXPERTS

21st-century experts in all aspects ranging from concept to market approval and post

FAST & EFFECTIVE SOLLUTIONS

We provide a flexible service customized to your specific demands and requirements

Strategic
Thinking

Thorough knowledge and understanding of global relevant directives and guidelines

OUR SERVICES

Market Approval

Product Authorisation

Medical Devices

Medical Devices

pharmacovigilance

PHARMACOVIGILANCE

QP & Batch Release

QP & Batch Release

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CASE STUDIES

Gene Therapy Company

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Medical Device Investigation in France and Spain

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Approval of Opiate Containing MP

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Global Update for Labeling due to New Core Safety Information

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Regulatory Know-How > Global Reach > Strong Network

Business without boundaries

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RECENT NEWS AND EVENTS

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