GMP Insiders - Your trusted source for GMP compliance!

Services

Unlock compliance and elevate your pharmaceutical operations with GMP Insiders

Quality Management System (QMS)

Are compliance challenges, inefficiencies, or deviation management holding your organization back? Let our tailored QMS services help streamline your operations and ensure success.

SERVICES	HOW WE CAN HELP	ACTIVITIES
🛠️ QMS Development and implementation	Create compliant, efficient systems	GAP Analysis, Process Mapping, System Design, and Training
📂 Document Control	Maintain accurate, audit-ready records	SOP creation, Version control setup, and Audit preparation
⚠️ Risk and Change Management	Proactively manage risks and changes	Risk assessments, Change control plans, and Impact analyses
✅ CAPA and Non-conformities	Address and prevent recurring issues	Root-cause analysis, CAPA plan development, and implementation
🚨 Complaint handling and Recalls	Resolve complaints and manage recalls swiftly	Complaint investigations, Recall action planning and Follow-up reporting
📊 Performance Monitoring	Track KPIs to optimize performance	KPIs identification, Dashboard setup, and Performance review

Validation & Qualification

Ensure operational reliability with our expert support in creating and managing validation documentation to meet regulatory requirements.

SERVICES	HOW WE CAN HELP	ACTIVITIES
📄Protocols & Reports	Develop precise, regulatory-compliant documentation.	Create validation protocols, test plans, and final reports.
⚙️ Equipment and Instrument Qualification	Prepare documents to ensure equipment and instrument reliability.	Draft URS, DQ, IQ/OQ/PQ protocols, and summary reports.
🔧Periodic Checks & Maintenance	Develop schedules, logs, and procedural documentation.	Provide structured plans and records for routine maintenance.
Design of GMP Cleanrooms and Laboratories	Ensure your facilities meet GMP standards for compliance and operational efficiency.	Develop GMP-compliant layouts, specify materials and equipment, and provide documentation for regulatory approval.
🏥Cleanroom Qualification	Deliver comprehensive cleanroom validation protocols.	Draft airflow test plans, particle count protocols, IQ/OQ/PQ protocols, and summary reports.
🧼 Cleaning Validation	Support cleaning process validation documentation.	Develop swab test plans, sampling procedures, validation protocols, and reports.
🔄 Process Validation	Assist in creating detailed process validation documents.	Prepare validation master plans, protocols, and final reports.
💻 Computer System Validation (CSV)	Provide complete documentation for system validation.	Develop risk assessments, test protocols, and traceability matrices.
🧪 Analytical Method Validation	Support validation of analytical methods with thorough documentation.	Create protocols, results analysis, and validation summaries.
🚚 Transport/Shipping Validation	Document processes to validate safe material transport.	Prepare route qualification protocols, temperature mapping plans, and reports.

GxP Training

Have trouble building a skilled and compliant workforce? Our GxP Training programs help your team gain the knowledge and tools to perform effectively.

SERVICES	HOW WE CAN HELP	ACTIVITIES
🎓Tailored Online/Onsite GxP Training	Deliver customized training materials for your team.	Develop course content, training guides, and assessments.
📊Training Matrix Development	Map out training needs to ensure regulatory readiness.	Create training matrices aligned with job roles and compliance standards.
🧠 Competence Matrix Development	Define and document required skills for every role.	Develop competence frameworks and evaluation criteria.
🗓️Development of Annual Training Plans	Plan structured, compliant training schedules.	Prepare annual plans, schedules, and associated materials.
📋Job Description Development	Define roles and responsibilities aligned with GxP.	Create job descriptions linked to training and competence needs.
🧑‍🏫Train-the-Trainer Programs	Equip trainers with resources for effective teaching.	Develop trainer guides, tools, and certification plans.
🚀Onboarding and Induction Program	Create structured onboarding processes for new hires.	Prepare induction guides, role-specific training plans, and checklists.

Inspection Readines / Audits

Prepare for inspections with expert support and documentation to ensure compliance and success:

SERVICES	HOW WE CAN HELP	ACTIVITIES
🔍Pre-Audit Preparation	Develop comprehensive plans to ensure audit readiness.	Create checklists, mock audit protocols, and gap analysis reports.
🏢Internal Audits	Support internal evaluations to identify and address gaps.	Develop internal audit procedures, templates, and reports.
🛠️Post-Inspection Support	Assist in addressing findings and implementing corrective actions.	Prepare CAPA plans, audit response letters, and follow-up reports.
🎓Inspection Readiness Training	Equip teams with the knowledge to handle inspections confidently.	Develop training guides, role-play scenarios, and response protocols.
📄Regulatory Audit Response Management	Provide structured support for managing responses to regulatory findings.	Draft response letters, corrective action plans, and progress reports.

Supply Chain Management

Facing difficulties with compliance, traceability, or risk in your supply chain? Our specialized consulting and documentation services ensure a seamless and efficient supply chain.

SERVICES	HOW WE CAN HELP	ACTIVITIES
📋Customer Onboarding & Qualification Procedures	Ensure smooth onboarding with clear, compliant procedures.	Draft onboarding protocols, qualification checklists, and review templates.
✅Supplier Qualification & Compliance	Verify and document supplier compliance with regulations.	Develop supplier audits, qualification protocols, and compliance assessments.
📦Qualification of Distributors & Wholesalers	Ensure your distribution partners meet quality standards.	Create qualification procedures, documentation templates, and approval reports.
🌍Compliance with Local & International Regulations	Stay compliant across all markets with robust documentation.	Prepare regulatory compliance guides, checklists, and monitoring tools.
🚚Good Distribution Practices (GDP) Compliance	Achieve and maintain GDP compliance in your supply chain	Draft SOPs, training guides, and GDP audit checklists.
✍️Quality Agreements	Define clear expectations with quality agreements.	Draft agreements, assist with reviews, and ensure compliance alignment.
🔗Supply Chain & Traceability Systems	Build traceable, compliant supply chains.	Develop traceability frameworks, documentation, and tracking protocols
⚠️Supply Chain Risk Management	Mitigate risks with proactive documentation and planning.	Create risk management plans, monitoring tools, and mitigation protocols.

Regulatory Affairs

Navigate complex regulations with expert documentation, strategy development, and lifecycle management:

SERVICES	HOW WE CAN HELP	ACTIVITIES
📄CMC Documentation & Technical Transfer Support	Ensure seamless technical transfers with clear documentation.	Draft and review CMC documents, prepare technical transfer dossiers.
♻️Regulatory Lifecycle Management	Manage the complete regulatory lifecycle of your products.	Maintain regulatory filings, monitor updates, and manage renewals.
🚀Support for Product Launches	Facilitate compliant and successful product launches.	Prepare launch dossiers, manage submissions, and assist with market entry.
📢Promotional Material Review	Ensure marketing materials meet regulatory standards.	Review promotional content, labeling, and advertisements for compliance.
📑Dossier Preparation, Updates & Gap Analysis	Ensure your dossiers meet regulatory expectations.	Prepare CTD/eCTD files, update submissions, and identify gaps.
🏷️Product Information & Labeling Updates	Keep product information compliant and up to date.	Revise labels, update prescribing information, and ensure regional compliance.
⚙️Variation Submissions & Change Control	Handle regulatory variations with precision.	Draft variation applications, manage change control, and track approvals.
🆕Marketing Authorization Renewals	Keep authorizations active with proper documentation.	Prepare renewal submissions, track timelines, and provide updates.
📬Regulatory Deficiency Letter Response	Address regulatory feedback effectively.	Draft responses, coordinate with stakeholders, and prepare additional data.
⚠️Risk Assessments (Nitrosamines, Elemental Impurities)	Ensure safety compliance with thorough assessments.	Prepare nitrosamine risk assessments and impurity reports.

Pharmacovigilance

Are you prepared to meet the challenges of drug safety and regulatory compliance? Our pharmacovigilance services provide the support you need:

SERVICES	HOW WE CAN HELP	ACTIVITIES
🛠️PV System Setup & Maintenance	Establish and sustain robust PV systems.	Develop PV master files, SOPs, and operational manuals.
⚠️Adverse Event (AE) & Safety Reporting	Ensure timely and accurate reporting of safety data.	Draft AE reporting templates, compliance checklists, and submission guides.
📋Risk Management Plans (RMPs)	Support the creation of detailed risk management strategies.	Prepare RMP documents, risk mitigation plans, and updates.
🔍Signal Detection & Risk Assessment	Identify safety signals and assess potential risks.	Develop signal detection reports, risk assessment protocols, and evaluations.
📝Periodic Safety Reports	Prepare comprehensive safety updates for regulators.	Draft PSURs, DSURs, and other safety summaries.
🏢PV Audits & Inspections	Ensure audit readiness and compliance.	Create audit plans, inspection guides, and CAPA responses.
🤝Safety Data Exchange Agreements (SDEAs)	Manage safety data exchange between stakeholders.	Draft and review SDEAs, ensure compliance, and maintain records.
📊Post-Marketing Surveillance	Monitor product safety after market launch.	Prepare surveillance plans, conduct safety analyses, and generate reports.

Quality Control

Ensure precise, compliant testing and monitoring with our QC documentation and system design services:

SERVICES	HOW WE CAN HELP	ACTIVITIES
📈Stability Studies Design & Reporting	Develop and document comprehensive stability studies.	Draft protocols, manage data collection templates, and create reports.
✅Data Integrity & Compliance in QC	Ensure compliance with data integrity requirements.	Create SOPs, audit trails, and data review checklists.
📊OOS, OOT & OOE Management	Support investigations for OOS, OOT, and OOE results.	Draft investigation templates, CAPA plans, and review reports.
🧪Raw Material & Component Testing Compliance	Ensure testing aligns with regulatory standards.	Create specifications, testing protocols, and compliance assessments.
📝Evaluation and Reporting of Results	Provide a robust approach for monitoring the validity of results	Establish statistical methodologies to implement decision rules for determining reportable results
🌱Environmental Monitoring	Ensure a controlled and compliant environment across the entire manufacturing premises.	Develop monitoring plans, establish sampling strategies, and create data trending reports.
🛠️Environmental Monitoring Program Implementation	Set up comprehensive environmental monitoring systems.	Draft SOPs, define sampling points, and implement monitoring tools.
💧Purified Water System Monitoring	Document and monitor water quality compliance.	Develop water sampling plans, testing schedules, and log templates.
🔬Microbial Identification & Testing	Support microbial testing with detailed documentation.	Prepare identification protocols, result templates, and validation reports.
🦠Microbial Limit Testing	Ensure testing complies with microbial limits.	Draft testing protocols, result forms, and compliance reports
🚨Sterility Testing & Aseptic Process Monitoring	Support sterility assurance programs.	Develop sterility test protocols, monitoring plans, and reporting templates.

Research & Development

Innovation and efficiency go hand in hand. Our R&D services help turn your ideas into successful, compliant products.

SERVICES	HOW WE CAN HELP	ACTIVITIES
🛠️Product Development	Support development of new products from concept to launch.	Draft development plans, product specifications, and validation protocols.
🔄Process Development	Optimize processes for efficiency and scalability.	Create process flow diagrams, validation protocols, and technical reports.
📐Quality by Design (QbD) Implementation	Integrate QbD principles into development projects.	Develop QbD frameworks, design space documents, and risk assessments.
🧪Analytical Method Development	Document precise and robust analytical methods.	Draft method development plans, validation protocols, and result reports.
🚚Technology Transfer	Ensure smooth transfer of technology between sites.	Create transfer plans, gap assessments, and support documentation.
🌱Green & Sustainable R&D	Incorporate sustainability into R&D activities.	Develop eco-friendly process designs, impact reports, and green initiatives.
💡Innovation & IP Support	Protect and enhance innovation with strong Intellectual Property (IP) support.	Draft patent filings, conduct literature reviews, and prepare invention disclosures.

Toxicology

Ensure regulatory compliance and safety with our expert toxicology documentation and assessment services:

SERVICES	HOW WE CAN HELP	ACTIVITIES
📄Study Design & Protocol Development	Create detailed study designs and protocols.	Draft study protocols, develop testing frameworks, and outline objectives.
⚠️Toxicology Risk Assessments	Identify and mitigate potential toxicological risks.	Prepare risk assessment reports, gap analyses, and mitigation plans.
✅Regulatory Toxicology Support	Assist with regulatory submissions and compliance.	Draft regulatory toxicology sections, compile safety data, and respond to inquiries.
📚Systematic Literature Review & Data Assessment	Provide thorough reviews and data analyses.	Conduct literature reviews, prepare data summaries, and evaluate findings (REACH, ECHA)
📋PDE Reports & Regulatory Documents	Prepare Permitted Daily Exposure (PDE) reports.	Draft PDE calculations, regulatory dossiers, and safety summaries.

Medical Devices

Do you need help managing the complexities of medical device regulations? Our expert services provide the guidance and documentation required to achieve compliance and bring your products to market.

SERVICES	HOW WE CAN HELP	ACTIVITIES
📄Regulatory Documentation & Submissions	Ensure devices meet global regulatory requirements.	Draft technical files, regulatory submissions, compliance reports, and dossiers.
⚠️Risk Management & Compliance	Identify and mitigate device-related risks effectively.	Develop risk management plans, hazard analyses, and compliance frameworks.
🗺️Regulatory Strategy & Consulting	Plan effective pathways to achieve device approvals.	Develop regulatory strategies, market entry plans, and compliance roadmaps.
🏷️Labeling, UDI & Product Information	Keep device labeling and identification fully compliant.	Draft labeling content, UDI submissions, and product information sheets.
🗂️Technical File Creation	Ensure comprehensive documentation for regulatory approval.	Compile technical files for MDR, IVDR, and FDA submissions.
💻Software Validation for Medical Devices	Validate software in compliance with regulatory standards.	Prepare validation protocols, risk analyses, and test reports.

ISO Consulting

Achieve ISO certification and compliance with our customized consulting and documentation services:

SERVICES	HOW WE CAN HELP	ACTIVITIES
🎓ISO Training & Awareness Programs	Equip teams with the knowledge to meet ISO standards.	Develop training materials, conduct workshops, and prepare awareness guides.
✅ISO 9001 QMS Implementation	Build effective quality management systems.	Draft policies, SOPs, and manuals for ISO 9001 compliance.
🏥ISO 13485 for Medical Devices	Ensure compliance with medical device quality standards.	Develop QMS documentation, risk management files, and audit preparation guides.
🌍ISO 14001 EMS Implementation	Implement environmentally sustainable practices.	Create EMS manuals, environmental policies, and compliance reports.
🦺ISO 45001 Occupational Health & Safety	Promote workplace safety and health compliance.	Prepare health and safety manuals, hazard assessments, and training guides.
🧪ISO 17025 for Testing & Calibration Labs	Ensure lab competence and accuracy.	Develop lab manuals, validation protocols, and quality control checklists.
🍽️ISO 22000 FSMS Implementation	Ensure food safety through ISO compliance.	Draft food safety policies, hazard analysis plans, and documentation frameworks.
🔄ISO 22301 Business Continuity	Build resilient business continuity systems.	Create continuity plans, risk assessments, and response procedures.