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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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