We provide compliance consultation and guidance for organizations in the pharmaceutical, biotech and medical device industries. In all GxP engagements, we strive for immediate and sustained process improvement, from product development to patient delivery.
Compliance Sustainability
A complete portfolio of resources for Compliance Sustainability
We combine our strategic consulting experience in regulatory compliance with our instructional design and training development capabilities to bring you the right resources to address your compliance challenge, distribute information to the people that need it, and sustain the gains you've achieved. We'll assess your unique challenges, develop a plan of action informed by Quality by Design principles, and build a Knowledge Base of training and documentation for sustained compliance.
LIFE SCIENCES
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 o 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
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—depends 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
CLINICAL
Compliance Sustainability
Raland Compliance Partners has over a decade of experience and a proven track record of success in clinical research compliance within the pharmaceutical, biotech and medical device industries. Our worldwide network of highly skilled personnel understands your need for complete, integrated, accurate and timely solutions. We provide compliance solutions that encompass your business needs and goals from product development to patient delivery.
Global Clinical Quality Assurance Auditing
Quality audits and assessments:
- Clinical Investigator Sites
- Phase I Units
- Trial Master Files (electronic and hard copy)
- Databases
- Software Validation
- Clinical Study Reports
Research vendor quality assessments and audits:
- Contract Research Organizations
- Data Management Vendors
- EDC Vendors
- Other Software Developers
- Clinical, Bioanalytical and Specialty Laboratories
- Statistical Vendors
- IVRS/IWRS Vendors
- Image Management Vendors
- Learning Management System Vendors
- Pharmacovigilance Vendors
- Academic Research Organization
Inspections/Mock Inspections
Raland Compliance Partners offers the knowledge and expertise of former FDA and other regulators to help our clients prepare for expected and unexpected Regulatory Authority inspections.
- Pre-approval Inspection Preparedness (PAI PREP)
- Third Party Audits/Assessments/GAP Analysis (GMP/GLP/GCP/QSR/ISO)
- Mock FDA/MHRA/EMEA/PMDA Inspections
- Due Diligence Audits & Assessments
Clinical & Pre-clinical Support
Raland Compliance Partners leads the way in providing clinical support through every step of the process.
- Clinical trial management
- Clinical quality auditing
- Clinical monitoring
- Clinical research training
- Clinical supply services
- Biostatistical consulting
- Data management
- Clinical pharmacology support
- Packaging & labeling compliance
- Vendor management
- Vendor qualification and audits
- Risk-based Clinical Monitoring Plan development or review
- Project management
- Global supply chain management
- QP support
- Global pharmacovigilance
- Software validation
- Regulatory readiness audits
- IRB/Ethical Committee assessments
- Service provider assessment (CRO, IVRS, EDC, etc.)
- Submission review and assessment
- Quality systems design and implementation
- SOP development and training
- Global Distributed Training — from traditional to multi media, from monolingual to multilingual
- Regulatory compliance (GxP)
- Investigator meetings
- Project training and support
Regulatory Affairs
Raland regulatory professionals can work with you to successfully navigate the ever-changing regulatory process.
- Preparation and review of regulatory submissions
- IND, CTA, eCTD, CTX, IDE, CTN, NDA, ANDA, MAA, BLA, PMA, and 510(k)
- Document control system assessment
- eCTD vendor audits
- Review and preparation of Drug Master File (DMF) and EDMF
- FDA 483/Warning Letter/Consent Decree response
TRAINING
Complete, single-source solution for your training and communication needs
The Communications division at Raland Compliance Partners provides a complete, single-source solution for clients, offering a wide array of services—from concept to delivery. Our experienced professionals come from many different communications disciplines and are able to create and implement all of your business communication needs.
- SOP training
- Clinical investigator and monitor training
- Performance support systems
- Multimedia design and programming
- 3D animation design and development
- Video concept, scripting and production
- Project management
- LMS support
Training Development and Delivery
Whatever your business, your people are your greatest asset. In order to optimize this asset, you need to provide high-quality and relevant training to ensure they have the latest knowledge and skills in your industry.
Our experienced training specialists hold advanced degrees in the fields of adult learning and instructional design. Our instructional design professionals will assess your current learning challenge to identify and create a training approach that works for you. From the initial concept through the final delivery and assessment, we’ll provide the highest quality training possible, enabling your staff to become top performers.
Technical Documentation
Communicating complex and technically intricate information is vital to your business. Our technical writers have years of experience working in many industries providing technically accurate, understandable, and user-friendly documentation—in hard copy and electronic formats. We use the latest development software and tools and methodologies to provide you with quality documentation.
- User guides
- Instructor guides
- Service manuals
- Spec sheets
- Technical documentation
- Business communications
- Marketing and promotional collateral
- Brochures
- Quick reference guides
- White Papers
Multimedia
Raland Compliance Partners offers a large variety of multimedia services for our clients. Our multimedia specialists bring years of experience and exceptional talent to our clients, providing the best service the industry has to offer.
We use the industry’s latest software tools and apply leading instructional methodologies to create, develop, and deliver an informative, engaging, and interactive experience.
- 2D/3D animation
- Video production
- Audio production/narration
LANGUAGE SERVICES
Translation & Language Services
Today’s business landscape spans the globe. To compete in this global marketplace, you must be ready to communicate with the world. The Language Services team at Raland Compliance Partners will help you succeed globally.
We provide translation services for many high-tech and professional industries around the world. Our staff includes professional translators and linguists who are experienced in providing services in the medical, legal, financial, and other professional service industries.
We are a proud member of the American Translators Association.
Software Globalization/Localization
Understanding business practices in foreign cultures is critical to localization success. To capitalize on opportunities and stay ahead of the competition, you need to do more than just translate words—you may need to adapt your product or service to accommodate local markets.
At Raland Compliance Partners, we have extensive experience in developing and implementing software solutions that provide localization support while ensuring the functionality of your product is maintained. In addition, our team of experts will work with your organization to ensure your product is well received, usable, and effective in various cultural environments.
CONTACT
LIFE SCIENCES
Robert A. Lawrence, VP & Executive Director of Life Sciences,
Tel: +01 847-852-4028, X 806, blawrence@raland.com
CLINICAL COMPLIANCE
Dorcie M. Jasperse, Executive Director of Clinical Compliance,
Tel: +01 847-852-4028, X 867, djasperse@raland.com
COMMUNICATIONS
Patricia Rader, Vice President of Communications,
Tel: +01 847-852-4028, X 814, prader@raland.com
LANGUAGE SERVICES
Olga Gulkewycz,
Tel: +01 847-852-4028, X 829, ogulkewycz@raland.com
GENERAL
info@raland.com
Your sustainable compliance and remediation partners
