Regulatory Compliance
GxP compliance support, FDA 483 response documentation, EMA audit preparation, and CDSCO regulatory filing. We handle the financial reporting requirements embedded in regulatory submissions.
Regulatory Compliance from LaabamOne
GxP compliance support, FDA 483 response documentation, EMA audit preparation, and CDSCO regulatory filing. We handle the financial reporting requirements embedded in regulatory submissions.
We combine deep healthcare domain knowledge with proven technology capabilities to help providers, payers, and life sciences organizations streamline operations, maintain compliance, and improve financial performance. Our clients include multi-specialty clinics, hospital chains, pharma manufacturers, and clinical research organizations.
Why LaabamOne for Regulatory Compliance
Combining Big 4 expertise with India pricing — delivered by a dedicated team that understands your industry.
Deep Industry Knowledge
Our professionals have worked inside healthcare organizations, financial institutions, manufacturers, and tech companies — we speak your language.
Regulatory Expertise
From HIPAA to SEC, GST to IRDAI — we understand the compliance landscape of your industry and build it into every engagement.
3-Country Coverage
Offices in India, Ireland, and Australia give you overlapping time-zone support and multi-jurisdiction expertise for global operations.
End-to-End Solutions
Accounting, tax, ERP, IT — we handle it all under one roof so you don't need multiple vendors for your industry-specific needs.
Other Healthcare & Life Sciences Solutions
Explore our full range of healthcare & life sciences capabilities.
Medical Practice Management
Revenue cycle management, insurance billing, patient collections, provider compensation, and multi-location financial co...
Hospital Financial Services
Cost accounting by department, DRG-based revenue analysis, capital budgeting for equipment procurement, fund accounting...
Clinic Accounting
Daily cash management, CPT code-based revenue tracking, provider productivity analysis, and overhead allocation across m...
Healthcare Compliance
HIPAA financial compliance, anti-kickback statute monitoring, Stark Law compliance, and False Claims Act risk mitigation...
Drug Development Accounting
Capitalization of R&D costs, milestone-based revenue recognition, partnership accounting, and FDA pre-approval expense t...
Pharmaceutical Tax Planning
R&D tax credit optimization (Section 41), orphan drug credits, transfer pricing for global pharma supply chains, and IP...
R&D Tax Credits
Identification and documentation of qualifying R&D activities, credit computation, and IRS/Revenue audit defense. We've...
Biotech Startup Services
Startup accounting, venture-stage financial reporting, investor reporting, cap table management, and bridge financing ad...
Clinical Trial Accounting
Trial budget management, CRO cost tracking, patient payment processing, site cost allocation, and ASC 730 R&D expense re...
Grant Management
NIH, ICMR, and Wellcome Trust grant accounting, effort reporting, cost sharing documentation, and OMB Uniform Guidance (...
IP Valuation
Valuation of patents, trademarks, trade secrets, and proprietary technology for M&A, licensing, litigation, and financia...
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