Industries: Pharmaceutical

Protecting consumer health and ensuring profitability

Today’s pharmaceutical companies are challenged to relentlessly fight a variety of illnesses while meeting regulatory requirements, reducing consumer class action suits, boosting consumer confidence, and protecting brand reputation.

In this most highly regulated industry, compliance risks complicate the entire product life cycle- from concept to clinical trials, manufacturing, and marketing- increasing the time and cost to market. Pharmaceutical companies strive to proactively manage compliance pressures to protect themselves against significant financial penalties, product withdrawals, operational shutdowns, and damaged reputations.

To do so requires a comprehensive compliance management backbone that transcends the traditional regulatory domains of legal, finance and executive management. Given the health liabilities associated with all phases of drug design, research, development, trials, changes, certification, manufacturing and release, a workflow and data management system of full-scope organizational reach must be implemented. Mitratech’s TeamConnect is the exclusive holistic solution that streamlines pharmaceutical workflow, lubricates inter-disciplinary collaboration, ensures procedural repeatability, and delivers the traceability of every input and touchpoint needed to prove process integrity.

Additionally, pharmaceuticals tackle counterfeiters, gray markets, and patent trolls to protect corporate profit margins and R&D investments. The activities tracking, data forensics and inter-disciplinary workflow that facilitates compliance equally supports the collaborative practices organized for enforcement of patents and protection of intellectual property.

Proactive management of diverse enterprise risks in pharmaceutical companies  strengthens brand assets and consumer confidence. Legal, compliance, and security concerns mandate a systematic risk management approach to protect consumer health and ensure profitability.

How TeamConnect helps

Mitratech’s TeamConnect solutions allow pharmaceutical companies to strategically manage legal and GRC concerns across the entire organization. Mitratech clients gain visibility into incidents of counterfeiting, manage informants securely, and collaborate with enforcement agencies on seizures, raids, and arrests.

TeamConnect allows internal departments to collaboratively manage with full visibility into:

Legal: Product liability; Mass Tort; Intellectual Property; Environmental; Regulatory; Mergers & Acquisitions; Contracts; Tax; Employment; Advice & Counsel

GRC: Food & Drug Administration (FDA) Regulations; Corrective And Preventive Action (CAPA); Prescription Drug Marketing Act (PDMA); CFR Title 21; Physician’s Labeling Rule (PLR); Occupational Safety & Health Administration (OSHA); Environmental Health & Safety (EH&S); Restriction of Hazardous Substances (RoHS); Environmental Protection Agency (EPA) regulations

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