Pharmacovigilance
The focus of drug safety and pharmacovigilance has increased substantially over the years.
The implementation of a sound process is essential to any pharmaceutical business. The safety
of the public starts with a system that encompasses monitoring, evaluating and reporting
efficiently while complying with regulatory authorities.
How we can help:
- Strategic set up of a drug safety and pharmacovigilance department from the ground up.
- FDA inspection readiness
- Writing/reviewing standard operating procedures, policies, work practices
- Medical review of drug safety cases
Medical Affairs
Getting the right information out to consumers, business partners and the medical community is vital for success.
Medical affairs is essential in supporting the other key players in the business from standard responses for
consumers to providing medical information to health care providers. Medical affairs also plays a key role in
medical review of advertising.
How we can help:
- Strategic set up of a medical affairs department from the ground up.
- Writing/reviewing standard operating procedures, policies, work practices
- Medical review of promotional material
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