EMMA International Consulting Group
Regulatory and quality consulting firm providing regulatory-submission support, quality systems design and implementation, remediation of inspection findings, data governance, and staff augmentation for medical device, combination product, diagnostic, pharmaceutical, food, cosmetics, and veterinary sectors. Services include QMS and eQMS implementation, regulatory strategy and filings, remediation and CAPA execution, training, outsourced regulatory/quality management, and sector-specific programs (FSMA, MoCRA, veterinary pathways).
Industries
Nr. of Employees
small (1-50)
EMMA International Consulting Group
Products
Quality and Regulatory Consulting
Consulting services focused on FDA regulatory affairs, compliance, quality systems, remediation, and regulatory filings for medical devices, biotechnology, and pharmaceuticals.
Project Management
Management of regulatory and quality projects to ensure timely and compliant execution within FDA-regulated industries.
Remediation
Services to identify, address, and resolve compliance deficiencies within FDA-regulated quality systems and processes.
Staff Augmentation
Provision of skilled regulatory and quality professionals to supplement client teams in FDA compliance activities.
Quality and Regulatory Consulting
Consulting services focused on FDA regulatory affairs, compliance, quality systems, remediation, and regulatory filings for medical devices, biotechnology, and pharmaceuticals.
Project Management
Management of regulatory and quality projects to ensure timely and compliant execution within FDA-regulated industries.
Remediation
Services to identify, address, and resolve compliance deficiencies within FDA-regulated quality systems and processes.
Staff Augmentation
Provision of skilled regulatory and quality professionals to supplement client teams in FDA compliance activities.
Services
Regulatory strategy, submission preparation and labeling support across medical device, pharmaceutical, cosmetics, food, and veterinary sectors.
Design and implementation of integrated QMS processes, SOPs, document control, training, audit-readiness programs and eQMS vendor selection/configuration.
Deployment of temporary or long-term regulatory, quality and technical SMEs or full teams to execute submissions, remediation, software QA, and QMS operations.
CAPA development, root-cause analysis, remediation planning and regulator-facing response support for inspection findings and warning letters.
Development of preventive controls, HACCP plans, traceability programs and recall preparedness for food and seafood supply chains.
GMP gap assessments, facility registration support, adverse event reporting readiness, ingredient and labeling review for cosmetics under MoCRA.
Regulatory strategy, submission preparation and labeling support across medical device, pharmaceutical, cosmetics, food, and veterinary sectors.
Design and implementation of integrated QMS processes, SOPs, document control, training, audit-readiness programs and eQMS vendor selection/configuration.
Deployment of temporary or long-term regulatory, quality and technical SMEs or full teams to execute submissions, remediation, software QA, and QMS operations.
CAPA development, root-cause analysis, remediation planning and regulator-facing response support for inspection findings and warning letters.
Development of preventive controls, HACCP plans, traceability programs and recall preparedness for food and seafood supply chains.
GMP gap assessments, facility registration support, adverse event reporting readiness, ingredient and labeling review for cosmetics under MoCRA.
Expertise Areas
- Regulatory strategy and submission management (medical device, pharmaceutical, veterinary)
- Quality management systems (QMS) design, implementation and certification readiness
- Electronic QMS (eQMS) selection and deployment
- Medical device software lifecycle and SaMD compliance
Key Technologies
- Electronic quality management systems (eQMS)
- Cloud-based QMS and regulatory-compliance software
- AI/ML for data governance and automated reporting
- Blockchain and electronic traceability systems (lot coding, CTI)
News & Updates
Overview of the FSMA Food Traceability Final Rule, traceability lot codes, critical tracking events and compliance dates.
Discussion of ALCOA+ principles, data governance, automated reporting, and training to support data integrity in pharmaceutical manufacturing.
Use cases for augmented reality in healthcare and guidance on software and device regulatory documentation, verification/validation and regulatory pathways.
Summary of cosmetics regulatory requirements, the Modernization of Cosmetics Regulation Act (MoCRA) implications, and the need for GMPs and ingredient/label testing.
Discussion of when companies should outsource regulatory and quality work, benefits of consulting and examples of outsourced support for software-enabled devices and submissions.
Identification of common regulatory challenges for biotech start-ups and recommendations for regulatory pathway selection, change monitoring, and QMS implementation.
Overview of the FSMA Food Traceability Final Rule, traceability lot codes, critical tracking events and compliance dates.
Discussion of ALCOA+ principles, data governance, automated reporting, and training to support data integrity in pharmaceutical manufacturing.
Use cases for augmented reality in healthcare and guidance on software and device regulatory documentation, verification/validation and regulatory pathways.
Summary of cosmetics regulatory requirements, the Modernization of Cosmetics Regulation Act (MoCRA) implications, and the need for GMPs and ingredient/label testing.
Discussion of when companies should outsource regulatory and quality work, benefits of consulting and examples of outsourced support for software-enabled devices and submissions.
Identification of common regulatory challenges for biotech start-ups and recommendations for regulatory pathway selection, change monitoring, and QMS implementation.