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SERVICES

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

Regulatory

  • 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

Electronic
Submissions

  • 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

Dietary Supplements/Nutraceuticals
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

  • 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

Preventative Action

  • 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

Audits

  • Quality Assurance oversight

  • Establishing Quality System document and control systems

  • Preparation of Standard Operating Procedures (SOPs)

  • Preparation of Quality Manual

  • Preparation of Quality/Vendor Agreements

Quality Systems

  • 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

Due Diligence

  • 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

DEA Systems

  • 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

Training

  • 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

Sourcing

  • 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

Project Management

As needed for a client’s project, 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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