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We offer an array of services for our clients including the following:



  • 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


  • 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


  • 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 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



As needed for a client’s projects, we also have an extensive network of global professionals who can avail their skills in matters of facility design, equipment and processing design, and project management to support your program(s).

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