Our expertise in regulatory requirements along with technical knowledge, enables ANP Pharma (London) Limited to provide a range of consulting services for analytical research and quality Assurance (QA) in the Pharmaceutical Industry.
Analytical Research and Development (cGMP)
→
Complete analytical Program Design
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Laboratory Design and Instrumentation
→ Validation Planning & Design
→ Validation Planning & Design
Quality Assurance (QA)
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Data Envelopment Analysis (DEA)
→
On-site Good Manufacturing Practice (GMP)/Good Laboratory Practices (GLP) /Good Distribution Services Training
→ Quality Management System
→ Regulatory Affairs
→ Quality Management System
→ Regulatory Affairs
Pharmaceutical Regulatory Affairs Services
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Dossier/submission preparation or review and filing
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Development of regulatory strategy for the product's life cycle
submissions and submission approval process
→ Work with Sponsors and regulatory authorities through the resolution of complex development issuess
→ Assist with due diligence activities for investors/licensees
→
Consideration of international regulatory requirements
→ Meeting international filings
→ Revision of plans as guidelines change
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Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, → Meeting international filings
→ Revision of plans as guidelines change
submissions and submission approval process
→
Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
→ Respond to regulatory agency questions
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Provide expert regulatory CMC compliance advice throughout development → Respond to regulatory agency questions
→ Work with Sponsors and regulatory authorities through the resolution of complex development issuess
→ Assist with due diligence activities for investors/licensees
Pharmaceutical Product Development Services
→
Comprehensive product development strategies meeting international standards, focusing on regulatory and toxicology requirements
→ Scientific writing of nonclinical data (safety), clinical data, and preparation of CMC documents
→ Manage nonclinical programs and Quality (CMC) components, and facilitate clinical programs to support registrations worldwide
→ Compliance activities, including development of compliance programs and conduct of facility for adherence to GLP and GMP standards
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Nonclinical studies required for next phase of Clinical Development
→ Management of Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, etc.
→ Timing and requirements for regulatory submissions to support on-going development activities
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Preparation, review, management and filing of submissions worldwide in Common Technical Document (CTD/eCTD) format→ Management of Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, etc.
→ Timing and requirements for regulatory submissions to support on-going development activities
→ Scientific writing of nonclinical data (safety), clinical data, and preparation of CMC documents
→ Manage nonclinical programs and Quality (CMC) components, and facilitate clinical programs to support registrations worldwide
→ Compliance activities, including development of compliance programs and conduct of facility for adherence to GLP and GMP standards
Supplier qualification and on-site GMP/GLP/GDP Audits
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Pharmaceutical Inspections
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Pharmaceutical Auditing for OTC Drugs
→ Supply Chain Program Management
→ Supply Chain Program Management
