CONSULTING BUSINESS
Best Consulting Ideas Awaits You !
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Our Vision
Our vision is deeply interwoven with our organizational culture, and goal in providing a broad range of services to provide unique solutions to ensure quality and regulatory compliance solutions in the Lifesciences industry.
Services
Our Services
We offer our expertise in assessing enterprise operations for compliance issues and formulate plans for improvement using our skills and know-how for efficient execution. Our services include, but are not limited to, consulting that fall under the following areas of FDA jurisdiction.
- Organizational Assessment for Statutory and Regulatory compliance.
- Compliance Matters in the Biotech, Pharma, Medical Device, Biologics, and other companies.
- Compliance Auditing
- FDA mock auditing for compliance-GMP, GCP, Pharmacovigilance (PV) etc.
- Customized Quality Training Programs-Medical Devices, Pharmaceuticals, Biotech, Therapeutics, and IVDs.
- FDA Inspection Preparation and Readiness
Regulatory Compliance & Quality Management
Omeramak Consultants help ensure high quality and regulatory compliance
AUDITING-GMP, GCP, GLP, BIMO Etc.
Our experts will help with the planning, conducting complete system assessments.
WHAT WE DO ?
Creative solutions by best business professionals.
Being a strong leader in the Lifesciences requires not just meeting specific requirements but also ensuring that clients are meeting their compliance needs by providing current regulatory requirements in all areas of the organization. We provide effective tools to our client organizations to deliver successful outcomes to meet their business needs.
Regulatory compliance requirements encompass the full product lifecycle, from development through approval, manufacturing, launch, and post market reporting activities. Having a good understanding of regulatory requirements and quality compliance require good insights and knowledge. Accordingly, our experienced and dedicated professionals are focused in providing valuable insights to guide client organizations across the pharmaceutical, biotech, and medical device industries.
We provide Quality Management services that not only diagnose nonconformities but also assist organizations with practical solutions. With over 25 years of expertise, we work collaboratively with our client to provide effective strategies to manage their Quality Systems including areas:
- System audits and assessments including pre-certifications and supplier qualifications.
- Document control
- Manufacturing and production processes
- Development of Standard Operating Procedures (SOP)
- Complaint Handling
- Corrective Action/Preventive Action (CAPA) processing
- Adverse Event (AE), and Medical Device Report (MDR) processes.
We also provide customized training on current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Quality System Regulations, ISO 13485 & 14971, EU Medical Device Regulations(MDR) formerly Medical Device Directives (MDD), auditing, and, related quality management topics to ensure teams are utilizing the current best practices.
INTRODUCTION
We provide you the best experiences
Consultancy: A clear understanding and interpretation of the current life science regulations require an in-depth knowledge on how to apply recognized standards to an organization’s facilities and operations. Our consulting services not only deliver an effective strategy for handling compliance issues, but our team of experts have the experience and skills to go beyond system assessments to work with clients to implement needed solutions.
Marketplace: We feature the highest quality of consumer products on our site. Go to our Marketplace for a selection of our featured products-SprinJene.
Aye W. Omuso, PhD
President/CEO
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