The non-clinical development phase is critical and sets the stage for everything that follows

Operations

Designated experts will be in charge of generating standard operating procedures (SOPs), individual case study reports, literature screening, and regulatory expedited reporting and storing real-world evidence (RWE) of adverse events conveyed by doctors and patients post-market.

SURVEILLANCE

Our specialized experts will perform analysis on the drug safety information collected and assist with the making and review of aggregate reports. The detailed reports will help your team to draw conclusions about the safety and efficacy of a drug or candidate molecule.

Systems

The pharmacovigilance systems division is constantly improving, and always keeping in line with, changing regulations and requirements for the health authorities/ business, making this a very challenging and vital aspect of pharma drug safety.

VETTED EXPERTS IN ALL 4 MAIN AREA OF PHARMACOVIGILANCE

Operations

Designated experts will be in charge of collecting, recording, and reporting data in all aspects regarding drug safety.

Surveillance

Experienced professionals in this area will assist any business or health organization through the safety and efficacy of a drug or candidate molecule.

Systems

We tackle this challenging and vital aspect of pharmacovigilance quality function by constantly improving, and always keeping in line with changing regulations to ensure drug safety.

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Consumer safety and constant vigilance

One of the most vital functions within a life science company is Pharmacovigilance. To develop, manufacture, and commercialize a drug a company must adhere to strict regulations.

Most of the protocols will focus on safety and the added benefit to the final consumer. This is the mission of drug safety and this is the reason why this discipline plays such a pivotal role within pharmaceuticals.

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WHY WORK WITH US

RegPakBioPharma Consulting is a specialist in the entire realm of pharmacovigilance (PV).

When it comes to strategic planning for product development, it can assist with the preparation and medical writing of key proofs of satisfactory pharmacovigilance that are required for marketing authorization by the Global Regulatory Authorities.