Our Services

Quality Assurance

We make the intelligent effort to employ quality initiatives and quality control methodologies to ensure Health Authority compliance. Our expertise includes GxP services, providing comprehensive support to tackle the multiple challenges of drug development and the dynamics of global clinical programs. Our QP services will help you deliver on-time quality Products to the market.

Our professionals are uniquely placed to engage as trusted scientific partners in the ultimate support of our clients. Our expanded capabilities include scientific knowledge and expertise, business insight, leadership and communication skills.
We help you bring your product to the market through Research and Development.

Regulatory Compliance

Our professionals work with clients to achieve their commercial goals by obtaining Health Authority approval to market their products.

Our expertise includes everything related to pharmaceutical development, from the earliest non-clinical studies to manufacturing and marketing.

We work with you in the initial application and ensure ongoing compliance with your product.

Our regulatory Expertise includes product Market Authorisation: Pre-approval – BLA/IND/NDA, Post-approval – Variations and Product Life cycle management.

Clinical Services

Our clinical professionals help you decide if you are ready to move into the clinical stage and which trials you should perform. At OMO Consultants, our expertise includes applying to conduct a clinical trial for an advanced therapy medicinal product (ATMP) and our team of experts helps you with the transitions from pre-clinical into clinical trials.

Specialised QP and RP Services

Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU/EEA require an MIA license and a designated Qualified Person (QP) and Responsible Person (RP), to oversee the product quality throughout the quality assurance (QA) process.

Our QA consultants bring a deep understanding of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) processes, to ensure compliant manufacturing and distribution of products in the EU market.

Our QP/RP services include:
• Named on your organisation MIA/WDA
• Partnering with your organization to lead or assist in obtaining the manufacturer’s import license and wholesale distributor license
• Building Quality Management Systems (QMS)
• Helping organizations develop a flexible staffing model that caters to specific needs ranging from long-term assignments (named on the client’s license) to interim support
• Providing around-the-clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk
• Providing full oversight of the QMS to maintain product quality in the distribution to pharmacies, hospitals, or other wholesalers

Pharmaceutical Training

Our experts in Operational Excellence possess the principles and tools to create sustainable improvements within your organisation. We work with you to enhance your company culture that will allow you to manufacture quality products and achieve long-term sustainable growth.

OMO Consultants provides all the necessary training you may need, from theory to practice. We provide on-demand training within our areas of expertise, with a real added value which is our hands-on experiences.

Our consultants are lean thinkers with Six Sigma methodology experience and certification. The consultants collaborate with you to manage your business and operational processes systematically to deploy the right culture within the business.