AYID Consulting
Consulting firm providing regulatory affairs, quality, validation, and formulation support to pharmaceutical, biotechnology, and medical device companies. Services focus on regulatory submissions and strategy, quality management system implementation, validation and remediation, and outsourced CRO/CMO setup.
Industries
Nr. of Employees
small (1-50)
AYID Consulting
630 Freedom Business Center Drive, King of Prussia, PA 19406, USA
Products
Primary CMC Preparation, Gap Analysis, Review and Assessment of Drug Product Development
Service involving preparation and evaluation of Chemistry, Manufacturing, and Controls (CMC) documentation and assessment of drug product development stages.
Drafting, Writing, Reviewing, and Compiling CMC Sections of Regulatory Submissions
Preparation and review of CMC sections for various regulatory submissions including IND, NDA, CTA, ANDA, DMF, CTD, and eCTD formats.
Development of Regulatory Strategy
Consulting service to analyze regulations and develop strategies to comply with healthcare laws and guidelines.
FDA Consent Decree Remediation
Support service to address and resolve FDA Consent Decree issues related to regulatory compliance.
Support with Validation Activities (IQ, OQ, PQ)
Consulting support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation processes.
Preparation of Regulatory Filings and CMC Sections for IND, IMPD, NDA, ANDA in CTD Format
Preparation and advisory service for regulatory filings and CMC documentation in CTD format for various applications.
Primary CMC Preparation, Gap Analysis, Review and Assessment of Drug Product Development
Service involving preparation and evaluation of Chemistry, Manufacturing, and Controls (CMC) documentation and assessment of drug product development stages.
Drafting, Writing, Reviewing, and Compiling CMC Sections of Regulatory Submissions
Preparation and review of CMC sections for various regulatory submissions including IND, NDA, CTA, ANDA, DMF, CTD, and eCTD formats.
Development of Regulatory Strategy
Consulting service to analyze regulations and develop strategies to comply with healthcare laws and guidelines.
FDA Consent Decree Remediation
Support service to address and resolve FDA Consent Decree issues related to regulatory compliance.
Support with Validation Activities (IQ, OQ, PQ)
Consulting support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation processes.
Preparation of Regulatory Filings and CMC Sections for IND, IMPD, NDA, ANDA in CTD Format
Preparation and advisory service for regulatory filings and CMC documentation in CTD format for various applications.
Services
Customized regulatory consulting and full-service management of regulatory submissions, including CMC section preparation and eCTD formatting.
Design and implement quality management systems and author or review standard operating procedures to support compliance.
Support IQ, OQ and PQ activities and other validation tasks for facilities, equipment and processes.
Provide remediation plans and implementation support for regulatory non-compliance, including consent decree remediation.
Assist with selection and setup of CRO and CMO partnerships, including oversight arrangements.
Support formulation development activities to advance drug product development.
Customized regulatory consulting and full-service management of regulatory submissions, including CMC section preparation and eCTD formatting.
Design and implement quality management systems and author or review standard operating procedures to support compliance.
Support IQ, OQ and PQ activities and other validation tasks for facilities, equipment and processes.
Provide remediation plans and implementation support for regulatory non-compliance, including consent decree remediation.
Assist with selection and setup of CRO and CMO partnerships, including oversight arrangements.
Support formulation development activities to advance drug product development.
Expertise Areas
- Regulatory compliance and submissions
- CMC dossier development and gap analysis
- Quality management systems and SOP development
- Validation and qualification (IQ/OQ/PQ)
Key Technologies
- CTD/eCTD regulatory submission format
- CMC documentation and dossier compilation
- Quality management system (QMS) processes
- Validation protocols (IQ/OQ/PQ)