Product Development and Manufacturing

Our experts help your organization with product development and manufacturing with a focus on:

  • Validation master planning
  • Facility, utility and equipment commissioning/qualification
  • Computer & software validation
  • 21CFR Part 11/EU GMP Annex 11
  • Cleaning validation
  • Process validation
  • Methods development & validation
  • Plant program development
  • Plant procedures and policies
  • Plant E-solutions
  • Technology transfer
  • Clinical and commercial manufacturing support
  • Formulation development
  • Process development
  • Supply chain management
  • Facility design
  • Plant controls and systems
  • Training and training systems

Quality Systems Implementation

  • ICH Q7A/Q9/Q10
  • FDA 210/211
  • DFA Part 11
  • FDA 820
  • ISO 9001
  • ISO 13485
  • ISO 14971
  • IEC 62304

Quality System Assessment

  • Compliance auditing
    • GMP, GLP, GCP, ISO, QSR
  • Compliance risk assessment and corrective action plan evaluation
  • Regulatory mock inspections
    • FDA, EMA, PMDA, MHRA
  • Quality assurance support
  • Quality control and analytical support
  • QP support
  • Analytical method development and validation
  • Design controls and quality systems
  • Strategic compliance advice
  • Development and implementation of corrective action plans (CAPA)
  • Regulatory action
  • Remedial and strategic solutions

Inspections/Mock Inspections

Raland Compliance Partners has the knowledge, expertise, and experience to help you prepare for inspections and audits.

  • Pre-approval Inspection Preparedness (PAI PREP)
  • Third-party audits and assessments
  • Gap analysis
    • GMP, GLP, GCP, QSR, ISO
  • Third-party certification
  • Mock FDA/MHRA/EMEA inspections
  • Due diligence audits and assessments

Compliance Solutions

Our associates have decades of experience designing, training, implementing, and auditing compliance programs in the areas of quality systems and risk management, and can perform gap assessments for compliance with pharmaceutical, biotechnology and medical device industry regulations (FDA, MHRA, EMA, KFDA). We work to optimize your compliance.

  • GxP compliance audits
  • FDA 483 and Warning Letter remediation and Corrective and Preventive Actions (CAPA)
  • Assessments and audits of BLAs, NDAs and ANDAs
  • Training and education in GxP (GMP, GLP, GCP)
  • Assess or develop SOPs for Quality Systems including Good Document Practices (GDP)
  • Research vendor quality assessment and audits
    • Pharmacovigilance
    • Contract Research Organizations (CROs)
    • Data management and statistical vendors
    • Software developers
    • Clinical and bioanalytical laboratories
    • IVRS/IWRS
    • Image management vendors
    • Learning Management Systems
    • GxP compliance audits
    • FDA 483 and Warning Letter remediation and Corrective and Preventive Actions (CAPA)
    • Assessments and audits of BLAs, NDAs and ANDAs
    • Training and education in GxP (GMP, GLP, GCP)
  • Assess or develop SOPs for Quality Systems including Good Document Practices (GDP)
  • Research vendor quality assessment and audits
    • Pharmacovigilance
    • Contract Research Organizations (CROs)
    • Data management and statistical vendors
    • Software developers
    • Clinical and bioanalytical laboratories
    • IVRS/IWRS
    • Image management vendors
    • Learning Management Systems
  • Quality assurance systems gap analysis
  • Software validation and quality audits
  • Vendor qualification
  • Initial qualification and inspection of suppliers, contract manufacturing, testing laboratories, and software developers
  • Laboratory method development and validation
  • Laboratory equipment validation

Plant & Operation Validation

Whether you're installing a new state-of-the-art automated packaging line or calibrating a balance, you must have complete control – and be able to prove it. We can help.

Our clients' success and credibility depend on their manufacturing facilities operating consistently and reliably year after year. We help our clients achieve the highest levels of efficient product throughput possible, for the highest level of profitability, while meeting industry regulations.

  • Life cycle and opportunity cost analysis
  • Global validation strategy and validation master plan
  • Project management
  • Gap analysis and risk mitigation
  • Process improvement
  • On-site staffing

Business Operations

  • Authoring of Standard Operating Procedures (SOPs)
  • Capital planning
  • Controls and automation (GAMP compliant)
  • Facility construction and relocation
  • Equipment specification, installation and validation
  • Design Specification (DS)
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Performance Qualification (PQ)
  • Supply chain and manufacturing optimization
  • Technology and Manufacturing Transfer
  • Validation operations
    • Cleaning validation
    • Method validation
    • Process validation
    • Validation metrology
  • Temperature distribution and penetration studies
  • Test script authoring and reviews

Laboratory Development & Validation

Method validation is universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry. The development of these methods is equally important.

The acceptability of analytical data corresponds directly to the criteria used to validate the method. You need to be able to document accuracy, precision, selectivity, sensitivity, reproducibility, and stability to demonstrate that the performance characteristics of the method are suitable and reliable for the intended analytical applications. At Raland Compliance Partners, we have developed hundreds of methods for use in industry in compliance with state, federal, and ICH guidelines set by USP, IUPAC, ISO, and AOAC. We can help you every step of the way.

Services

  • Annual lot analysis
  • Equipment specification and selection
  • Equipment installation and validation
  • IQ, OQ, PQ
  • Laboratory Information Management Systems (LIMS)
  • Laboratory design, installation and qualification
  • Method development and validation (on-site)
  • Remediation of regulatory issues (FDA 483)
  • Stability program development
  • Standard Operating Procedure (SOP) authoring
  • Technology transfer
  • Training
  • Vendor auditing

Computer System Validation

Your credibility depends on meeting the guidelines set forth by the Code of Federal Regulations Section 21, Part 11 (21 CFR Part 11) and EU GMP Annex 11 for electronic documents and signatures. Raland Compliance Partners understands global requirements and industry regulations. We work to help you meet and exceed them.

We've developed an innovative program called PAR (Planning/Action/Results) to help our clients maneuver through and meet regulatory requirements. Using a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis, we'll develop a customized plan for your business to determine accurate, actionable, and achievable steps that yield results.

  • Software Validation
  • Building Automation Systems
  • Laboratory Equipment Qualification
  • Laboratory Information Systems
  • Quality Management Systems
    • CAPA and CAPA effectiveness
    • Electronic Document Management Systems
    • Investigations and Deviations
    • Audit Tracking
    • Customer Complaints
    • Adverse Events
    • Change Control
    • ERP/MRP Systems
  • Data Centers
  • FDA Part 11 and EU GMP Annex 11 Assessments