Consultants

Quality Management Systems (QMS)

Concerned your quality system doesn't reflect FDA expectations? Connect with former FDA and industry professionals who have extensive knowledge of FDA's current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.

• GxP Audits

• QMS Process & Procedure Development

• Gap Assessments

• QMS Remediation

• Quality Unit Resourcing

Non-Conformance & CAPA Management

Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.

• Non-Conformance/Deviation Investigation Management Support

• Process Analysis & Enhancement

• Investigation, Action Plan, & Effectiveness Check 

Regulatory Compliance

Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.

• Regulatory Observation/Warning Letter Responses & Remediation

• PAI & Inspection Readiness

• Internal Audit & Remediation Services

We'll work with you in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully develop due diligence strategies. Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.

• Review of client technical dossiers and developmental plans
• Research and interpretation of regulations
• Determination of regulatory status
• Pre-submission review of technical documents
• Critical writing and review of documentation
• Clinical trial applications and notifications (IND, IDE, CTX, etc.)
• Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
• Orphan Drug, Treatment Use, and ANDA Suitability petitions

Our experts prepare all major regulatory submissions and provide extensive quality control review for all trial-related documentation, such as:

• Regulatory Agency and IRB/EC submissions
• Procurement of Import/Export license
• Initial submissions, amendments, notifications, and closeout submissions

Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:

• Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
• Coordinating clinical trial application filings to regulatory agencies
• Ensuring submissions comply with regulations
• Managing submissions and document storage processes
• Staying abreast of all regulations to ensure documentation compliance

Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.

Demand for talented clinical operations professionals grows each day. How do you find the resource you need when you need them? Through years of connecting clinical operations experts with opportunities around the world, we’ve developed a large active, and extended pool of talented professionals.

• Fill in-house staffing gaps and scale your clinical operations to meet changing demands
• Cost-effectively acquire the talent you need, where you need them
• Work towards accurate and timely completion of your clinical trials
• Cut down on administration, better control your overhead, and reduce turnover

We can fulfill clinical contracted and direct hire resource placement needs in a variety of roles and functions including, but not limited to:

• Clinical Operations
• Clinical Project Management
• Clinical Monitoring
• Biometrics & Data Management
• Medical Writing

We work with our clients to develop scalable resource plans to support validation efforts throughout the project lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our resources have you covered.

• Validation Master Plans (VMPs)

• Design Qualification (DQ)

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

• Equipment Validation

• Software Validation

• Process Validation

Our consultants, many of whom are former FDA, are experts in the science and activities related to detecting, evaluating, understanding, and preventing adverse effects associated with pharmaceutical and medical device products. Teams work with us when they want to ensure the safety of their products throughout their lifecycle.

Pharmacovigilance System Development and Maintenance

Building and maintaining an effective pharmacovigilance system is critical for ensuring the safety of your products. Our services in this area include, but are not limited to:

• SOP Development and Review
• Safety Data Exchange Agreements
• Company Core Datasheet (CCDS) Maintenance
• Safety Database Management
• Global Safety Committee Activities
• PV Quality Management System

Operational Pharmacovigilance Support

Managing day-to-day PV activities can be complex and resource-intensive. Our experienced consultants provide comprehensive support, ensuring all aspects of your PV operations run smoothly. Our services in this area include, but are not limited to:

• Handling Safety Information
• Adverse Event Management
• Clinical Trial Support
• Pharmacovigilance Audits
• Medical Information Management
• Aggregate Safety Reporting

Advanced Pharmacovigilance Consulting

Our resources also provide strategic oversight and specialized expertise to enhance your PV system. Our services in this area include, but are not limited to:

• Signal Management
• Risk Management Plans (RMP) and REMS
• Benefit-Risk Communications
• Regulatory Inspection Support
• Strategic PV Consulting
• Safety Variations and Urgent Safety Restrictions