Capabilities:

Our deep understanding of industry laws and regulations, innovative and practical applications and custom solutions help our clients establish a “Culture of Compliance" that is both meaningful and practical.

Our deep understanding of industry laws and regulations, innovative and practical applications and custom solutions help our clients establish a “Culture of Compliance" that is both meaningful and practical.

Expertise and knowledge across all areas of compliance:

• Policy & SOP Development, Review & Harmonization
• Risk Management Processes, Audits & Assessments
• System Evaluation, Implementation & Validation
• Training Development & Delivery
• Strategic Outsourcing

Sunshine Act:

• The Physician Payments Sunshine Act aims to limit aggregate spend per physician and mandates statutory reports every quarter.



• Goal of this act is
• Provide transparency to relations between pharmaceutical, biologics, device and diagnostic manufactures and HCP/O.
• Several states have already passed law requiring public disclosure of financial payments and other considerations given to HCP/O including specific prohibitions and spend caps.


• Legislation is attempting to address to primary concerns
• Appearance of a conflict of interest whereby prescribing behaviors maybe influenced by promotional activities by the manufactures.
• Overall prescription rates are rising dramatically and with Americans guaranteed coverage, the country as a whole is spending more on drugs than ever before.

Our services Include:

• MDM Approach – to establish a clean, comprehensive and single version of Master Data. We initiate a MDM study in collaboration with clients IT department to establish the solidity of the foundation on which the entire compliances systems rests.
• Data Scrubbing – verify and validate transaction data against all available Master Data resources of the company. Provide manual data scrubbing assistants who will investigate, search, call, verify and resolve all instances of doubt flagged by the data scrubber.
• Data capture strategy - The data integration challenge requires a data capture strategy that can be sufficiently flexible, scalable and adaptable to integrate transactional data from multiple, legacy and source systems.
• Integration of data - The need to integrate data for compliance tracking and reporting at the transactional level, across enterprise systems is becoming a focus for many pharmaceutical business and IT departments.
• Customer master list - As requirements for the state reports become more complex, it is important to have access to an integrated (enterprise wide) customer master list.
• Reports – we provide a reporting tool that generates required reports. It stores all report formats and templates.
• Data Mining and search engine – ad hoc searches for any kind of investigation into the database, whether it relates to regulatory laws, clean transactional data, reports and alerts.

21 CFR Part 11 Compliance:

The FDA rule relating to use of Electronic Records and Electronic Signatures is an effort by the FDA to set minimum compliance guidelines for systems working in pharmaceutical, medical device and bio technology industry.

Our services include -

• Planning and Assessment study
• Security
• Audit Trails
• Documentation controls
• Training