Innovative Business Consulting

Revolutionizing the way you do Business Consulting in regulatory compliance world

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About Your Compliance Partner

Our Vision

Our Approach

Our Vision

At Your Compliance Partner, our vision is to be the leading consulting firm in the industry. We aim to achieve this by constantly innovating and providing exceptional services that exceed our clients' expectations.

Our Team

Our Approach

Our Vision

Our team comprises of highly skilled consultants with extensive experience in various industries. We are committed to delivering quality services to our clients and helping them achieve their business goals.

Our Approach

We take a data-driven approach to consulting, where we use advanced analytics and technology to provide insights that drive business decisions. Our approach is highly customizable to meet the unique needs of each client.

Our Services

Our Approach

We offer a wide range of consulting services, including strategy, operations, and technology. Our services are designed to help our clients achieve sustainable growth and long-term success.

Regulatory and IT/Software Consulting Services include:

Regulatory Strategy Development

Compliance Assessments, Gap Analysis and Audits

Regulatory Submissions and Approvals

End-2-End Strategic services from inception to commercialization, utilizing our specialized expertise in drug development, clinical trial design, CMC consulting, medical device design/development, and cosmetic safety assessments.

Regulatory Submissions and Approvals

Compliance Assessments, Gap Analysis and Audits

Regulatory Submissions and Approvals

Determine best suited approaches for various product registrations in the global market, encompassing regions such as the US, EU, Japan, Canada, Australia, and the Rest of the World (RoW).
Our expertise helps identify the optimal pathways tailored to specific markets and regulatory requirements worldwide, ensuring effective submissions and approvals.

Compliance Assessments, Gap Analysis and Audits

Introduction and sustainment of Quality Management Systems

Ensuring compliance in the pharmaceutical and Medtech landscape requires in-depth knowledge in regulatory compliance.
Comprehensive regulatory gap analysis and technical assessments allows manufacturers to proactively identify and address gaps prior to submission, thereby reducing the rate of rejection and expediting approvals.
On-site/Off-site auditing services are offered to support implementation and maintenance of MDD, MDR, MDSAP, UKCA, and Drug GMP compliance.

Introduction and sustainment of Quality Management Systems

Seasoned experts in Quality Management Systems (QMS), boasting extensive experience across start-ups and Fortune 100 companies.
We excel in achieving, maintaining, and enhancing ISO 13485 and MDSAP certifications within the medical device industry.
Offer valuable assistance in establishing and managing risk management files in accordance with ISO 14971.

Labeling and Packaging Compliance

Introduction and sustainment of Quality Management Systems

Post-Market Surveillance and Regulatory Intelligence

Offer exceptional support in pre-approval label reviews and label development
Optimizing labeling for maximum claims and accelerated product approvals
Post-approval label reviews to ensure compliance with the marketing authorization and identify any potential need for supplemental filings with Regulatory authorities.
With a team of highly qualified medical experts, we can guarantee that the labeling documentation provided to patients and healthcare practitioners contains the most current and relevant information available.

Post-Market Surveillance and Regulatory Intelligence

Introduction and sustainment of Quality Management Systems

Post-Market Surveillance and Regulatory Intelligence

Provides assistance in devising an appropriate PMS strategy, establishing a PMS plan, and selection of a CRO for PMCF-/PMPF studies.
Create essential reports such as the Post Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP), Manufacturer Incident report (MIR), Periodic Summary reports, Trend reports, and Field Safety Corrective Actions and Notice (FSCA).

Remediation and Enforcement support

Our team of global Risk & Compliance professionals collaborates closely with our clients to ensure comprehensive and timely responses to regulatory matters.
Execution of effective steps to remediate any issues, validation of successful resolution for these matters, and establishment of robust frameworks to confidently manage risks associated with these processes.

IT/Technology Consulting

Remediation and Enforcement support

PPC Management - Professionally managed search engine pay-per-click campaigns.
Search Engine Optimization - Increase rankings in the organic section of the search results.
Website Development - Website designed beautifully and responsive for all devices.
Mobile App Development - Create practical and seamless experiences on any device and get the best of mobile technology for your business.
Digital Marketing - We expand your business into new areas and achieve tremendous accomplishments in your industry.
Project Management Consulting - Using Lean/Agile principles, we deliver assessments and project management support
Key capabilities - Angular CLI, ASP .NET Core, Node JS, Ionic, Laravel/codeigniter, React

YourCompliancePartner

Innovative Business Consulting

About Your Compliance Partner

Our Vision

Our Approach

Our Vision

Our Team

Our Approach

Our Vision

Our Approach

Our Approach

Our Approach

Our Services

Our Approach

Our Approach

Our Clients Speak for Us

Our Partners

The greatest glory in living lies not in never falling, but in rising every time we fall.

Regulatory and IT/Software Consulting Services include:

Regulatory Strategy Development

Compliance Assessments, Gap Analysis and Audits

Regulatory Submissions and Approvals

Regulatory Submissions and Approvals

Compliance Assessments, Gap Analysis and Audits

Regulatory Submissions and Approvals

Compliance Assessments, Gap Analysis and Audits

Compliance Assessments, Gap Analysis and Audits

Introduction and sustainment of Quality Management Systems

Introduction and sustainment of Quality Management Systems

Introduction and sustainment of Quality Management Systems

Introduction and sustainment of Quality Management Systems

Labeling and Packaging Compliance

Introduction and sustainment of Quality Management Systems

Post-Market Surveillance and Regulatory Intelligence

Post-Market Surveillance and Regulatory Intelligence

Introduction and sustainment of Quality Management Systems

Post-Market Surveillance and Regulatory Intelligence

Remediation and Enforcement support

Remediation and Enforcement support

Remediation and Enforcement support

IT/Technology Consulting

Remediation and Enforcement support

Remediation and Enforcement support

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Your Compliance Partner

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