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We offer an array of services for our clients including the following:
Regulatory - US Agent for FDA requirements
- Preparation and submission of electronic Site Establishment/Labeler Code Assignment, and Drug Listings
- Preparation of electronic annual updates for Site Establishment Registration and Drug Listings
- Identifying and resolving non-compliant practices and conditions
- Compliance with FDA regulatory actions, including preparation of written responses, i.e. FDA Forms 483, Warning Letters, and Consent Decrees
Electronic Submissions - Electronic Common Technical Document (eCTD) submissions
- Preparation of pre-IND meetings
- Assembly and submission of INDs, NDAs, ANDAs, and DMFs (human or veterinary)
- Preparation of INDs, NDAs, and ANDAs with a focus on CMC sections
- Preparation of annual updates for all submissions to maintain active status
Dietary Supplements/Nutraceuticals - 21 CFR Part 111 - CGMP Regulations for Dietary Supplements
- Gap Assessment Audits
- Preparation for FDA inspections-What does FDA expect
- Compliance for APIs and Finished Products
Corrective and Preventative Action (CAPA) programs and initiatives - Corrective Action
- Responses to FDA Forms 483, Warning Letters, Consent Decrees
- Recall plans
- Prepare and revise documents and procedures
- Initiate equipment qualification plans
- Initiate validation protocols and plans
- Develop proper sampling plans and techniques
- Develop analytical procedures for assay, impurities and residual solvents determinations
Preventative Action - Identify and correct GMP deficiencies proactively, and develop CAPA initiatives
- Evaluate Quality Systems (QA/QC)
- Evaluate Document Control System, including SOPs, Master Production, Packaging, and Analytical
- Testing and Specification Records
- Evaluate Equipment Qualification, Process, Analytical, and Cleaning Validation Protocols and Reports
- See Corrective Action above
Audits - Preparation for FDA and MHRA Pre-Approval Inspections
- Preparation for Client Audits
- Audits and qualifications of key vendors, i.e. manufacturers of APIs (drugs and dietary ingredients), key starting materials, unique excipients,
finished dosage forms, components, and contract testing laboratories.- Audits of clinical research organizations, clinical sites, and depots
- Monitoring of CRO projects
Quality Systems - Quality Assurance oversight
- Establishing Quality System document control systems
- Preparation of Standard Operating Procedures (SOPs)
- Preparation of Quality Manual
- Preparation of Quality/Vendor Agreements
Due Diligence - Audits of manufacturing sites for compliance with pertinent FDA GMPs, and other requirements
- Review of NDAs, ANDAs, and Drug Master Files for confirmation of status, and compliance with FDA requirements
- Review of status of Vendor Qualifications of manufacturing sites for active pharmaceutical ingredients, key starting materials, unique excipients,and all finished product dosage forms
DEA Systems - Evaluation of Security System designs
- Audits for existing or planned facility design
- Compliance audits
- SOP Manual for Handling Controlled Substances
- Training of R&D, analytical, production, Quality, and warehouse personnel in handling and accountability of Controlled Substances
Training - FDA, DEA, and OSHA training programs
- GMP, GLP, and GCP Training
- Pre-Approval Inspection training
- GMP Training for APIs, Drug Products, Dietary Ingredients, and Dietary Supplement Products
- FDA/ICH guidance’s and initiatives for stability, impurities, and residual solvents
Sourcing - Sourcing of APIs, finished dosage forms, equipment, and analytical services
- Verification of source capabilities, FDA regulatory history
- Verification of status of DMFs for APIs
- Verification of NDAs, ANDAs for finished dosage forms
Project Management - Clinical trial material logistics and operations management
- Work with contract research organizations to meet clinical timelines
- Prepare and manage integrated project timelines
- Liaison between organizations
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