Regulatory1 is a consulting firm that provides regulatory, quality, and compliance services to medical device and pharmaceutical companies. Their services include regulatory strategy, project management, technical documentation preparation for approval, auditing, ISO compliance, clinical trials, testing, and more. They specialize in assisting both large and small clients with FDA and other regulatory requirements. They also offer internal audit services to help companies improve risk management, governance, and controls. Their audit services include regulatory compliance audits, certification support, third party audits, and FDA mock audits.

1. 2015
Auditing, Consulting and Compliance
T2, 3rd
Floor, Planet Vista,
RMV, 2nd
Stage, Sanjay Nagar,
Bangalore -560094

2. About Regulatory1:
Regulatory1 is a consulting firm for Medical Device, IVD and Pharmaceutical
companies. The Services include regulatory consulting in terms of Strategy, Project
Management, Preparing Technical Documentation, and Audit Support for
Regulatory Approval, Certifications, Third Party Audit, and Device testing as per
regulatory requirement, biocompatibility (ISO 10993), preclinical testing, clinical
trials, ISO compliance, packaging testing, EU and FDA requirement.
Regulatory1 specializes in providing regulatory, product development and quality
systems consulting services to manufacturers of medical device products. Our
medical device expert has over 10 years of combined experience of Medical Device
and IVD sector. We can assist clients (both large and small) in regulatory strategy,
preparation of FDA submissions, product manufacturing and testing,
biocompatibility, clinical trial design and evaluation, and QSR regulatory
compliance. We offer consulting services and regulatory support based on a full
understanding of FDA regulatory expectations and policies.
Audit Services:
The dynamics of today’s global business environment are driving organisations
everywhere to seek new ways to improve their competitive advantages. Across
industries and organisations, many business leaders are recognising that risks are
no longer merely hazards to be avoided but, in many cases, opportunities to be
embraced. However, stakeholders also recognise that excessive risk taking can
adversely affect organisations and, in extreme cases, may even lead to their
collapse, as demonstrated by several spectacular corporate failures in the past few
years.Demand for high quality internal audit services has therefore grown
exponentially as the global awareness of the importance of good corporate
governance, effective risk management and appropriate internal controls continues
to grow.
Over the last five years, the Internal Audit Services (IAS) practice has grown
significantly. Today, we provide a full spectrum of advisory services tailored to the
specific requirements of clients all over the world.
T2, 3rd
Floor, Planet Vista,
RMV, 2nd
Stage, Sanjay Nagar,
Bangalore -560094

3. AUDIT
 Regulatory Compliance Audit
 Internal Audit
 Certification Support Audit
 Third party Audit
 FDA Mock Audit (21 CFR 820)
REGULATORY CONSULTATION
 Regulatory Strategy
 Project Management
 Technical Documentation support for Regulatory Submission
 CE Marking, Design Dossier. 510(K) documentation,
 ISO 13485 QMS documentation and Implementation
 Protocol writing for ISO 10993 and Clinical Trials
TESTING:
 Biocompatibility ISO 10993
 Mechanical Testing as per ASTM standards
 Preclinical Studies
 Clinical Studies
 Packaging Testing as per ASTM/ ISO standards
 Analytical Testing as per ASTM
T2, 3rd
Floor, Planet Vista,
RMV, 2nd
Stage, Sanjay Nagar,
Bangalore -560094