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Risk Management
Increased pressure from regulators, including stricter compliance guidelines for transparency, has placed greater accountability on pharma to identify and make visible the true benefit-risk associated with each medicine.
Today effective pharmaceutical risk management is critical to successful drug development and commercialization. In recent times, the FDA and EMA have released risk management guidance documents that emphasize the need for risk management throughout the life cycle of a drug. In this evolving regulatory environment, risk management has always been an intrinsic part of the world of pharma – with the decisive calculation of benefit-risk for each medicine serving as the ultimate determinant for drug and patient safety.
MakroCare consulting works with different regulatory agencies to shape, implement and refine risk management practices.
It can be applied to different aspect of pharmaceutical quality including development, Manufacturing, Distribution, Inspection, submission and review processes through out the life cycle of drug substances, drug product, biological and biotechnological product (including use of raw material, solvent, excipient, packaging and labeling.)
Some of our Deliverables Include:
- Risk assessment & Evaluation plans
- Risk management plans (REMS, EU-RMP, etc)
- Risk/benefit reports
- ICH E2E pharmacovigilance plans
- Designs of post-approval studies
- Designs for evaluation of RMPs
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