Regulatory Compliance

The regulatory environment for life sciences companies is known for its challenging complexity. And with thousands of new and changed regulations and guidelines released each year, compliance can be a painful and costly ordeal.

Globalization is forcing companies large and small to find more efficient ways of tracking varying regulations and rapid rule changes. And as new technologies and industry standards emerge, regulatory harmonization and compliance management initiatives are driving life sciences companies to build new systems and processes to comply with mounting guidelines.

Given the exorbitant cost of non-compliance, successful life sciences companies need a strong compliance foundation, including compliance with corporate objectives and policies, working procedures and guidelines and regulator’s requirements.

We have a demonstrated track record of helping global top 10 pharmaceutical, biotech and medical device companies audit and maintain regulatory compliance by optimizing costs and improving process efficiencies. Our audits cover process adequacy, maturity, physical infrastructure, information security and IP protection. Our regulatory compliance portfolio includes:

  • Knowledge Process Outsourcing (KPO) services for regulated and critical business processes, such as submissions management, labeling and digital asset management, pharmacovigilance case processing, clinical data management and analytics.
  • Independent validation services: enabling computer systems compliance in optimal time and cost.
  • Application development and maintenance services that are fully 21 CFR 11 and CSV compliant.
  • Consulting services, including COTS (Off the shelf product) Evaluation for Part 11 compliance, SPRing (Submission Process Reengineering framework), and ReguWatch (e.g., evaluating the impact of global regulatory updates on processes and systems).

Our success results from a clear understanding that regulatory compliance cannot be viewed in isolation but requires a holistic approach. Whether we are developing a regulated application, maintaining the validated state of an application, or executing mission critical business processes, our standard operating procedures facilitate compliance with various industry standards related to process maturity, information security management, FDA guidelines on computer system validation and electronic records and signatures.

And our quality management system has the highest benchmark ratings against industry standards such as ISO 9001, ISO 13485, ISO 14971, SEI-CMMi and BS7799. Compliance with 21 CFR 11 and CSV guidelines is also built into our quality management system.

By working with us you’ll have access to our dedicated and first of its kind Office of Regulatory Affairs & Compliance (ORAC). Staffed with certified consultants on Regulatory Affairs (RAC) and consultants with documented industry experience, ORAC takes accountability for compliance in our engagements and provides thought leadership to the industry.

Make regulatory compliance more manageable, cost-efficient and water-tight by taking advantage of our integrated portfolio of services.