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MEDICAL DEVICES

Quality Services

MEDICAL DEVICES

Regulatory Services

Quality Management System (QMS) Services

QMS Development & Implementation (ISO 13485:2016, FDA 21 CFR Part 820, ISO 9001:2015)
QMS Audits (Internal, Supplier, Mock FDA, MDSAP)
QMS Remediation & Gap Analyses
Quality System Documentation (SOPs, Work Instructions, Templates)

Compliance Support & Advisory Services

FDA Quality System Regulation (21 CFR Part 820) Compliance
ISO 13485 & ISO 9001:2015 Compliance Advisory
CAPA & Complaint Handling Strategy & Implementation
Risk Management & ISO 14971 Compliance Guidance
EU MDR & Post-Market Surveillance (PMS) Strategy
Audit Readiness & Regulatory Compliance Planning

Regulatory Compliance & Audits

FDA Pre-Inspection Readiness & Support
FDA 483 & Warning Letter Remediation
Adverse Event Reporting & Remediation
Notified Body Audit Preparation (MDSAP, EU MDR)
Supplier & Vendor Audits (ISO 13485, FDA, EU MDR)
Process Audits & Quality Audits

CAPA & Nonconformance Management

Corrective & Preventive Action (CAPA) Development & Implementation
CAPA Investigation & Root Cause Analysis
Nonconformance Handling & Documentation
CAPA Effectiveness Checks & Continuous Improvement

Risk Management & Post-Market Surveillance (PMS)

Risk Management File Creation (ISO 14971:2019)
Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF)
Complaint Handling & Adverse Event Reporting (FDA, MDR, MHRA)
Medical Device Reporting (MDR) & Vigilance Reporting

Design & Manufacturing Quality Compliance

Quality by Design (QbD) Implementation
Design Control Documentation (21 CFR Part 820.30, ISO 13485)
Design & Development Changes Compliance
Design History File (DHF) & Device Master Record (DMR) Development
Process Validation (IQ/OQ/PQ) & Test Method Validation
Quality Engineering Support
Software as a Medical Device (SaMD) Compliance (IEC 62304, FDA, EU MDR)

Production & Process Controls

Good Manufacturing Practices (GMP) Compliance
Sterilization Validation & Environmental Health & Safety (EH&S) Compliance
Labeling & Unique Device Identification (UDI) Compliance (FDA, EU MDR)
Statistical Process Control (SPC) & Continuous Process Improvements

Change Control & Documentation Compliance

Change Control Procedures & Documentation
Engineering Change Orders (ECO) & Document Control
Regulatory Submission Support for Design & Manufacturing Changes

Supplier Quality & Outsourced Manufacturing Compliance

Supplier Qualification & Audits
Supplier Risk Management & Monitoring
Contract Manufacturer Oversight & Compliance

Regulatory Strategy & Product Classification

FDA & Global Regulatory Strategy Development
Product Classification & Determination (FDA, EU MDR, MHRA, TGA, Health Canada, etc.)
Pre-Submission (Q-Sub) Meetings with FDA
Regulatory Risk Assessment & Gap Analyses

U.S. FDA Regulatory Submissions

510(k) Premarket Notification Preparation & Submission
De Novo Classification Requests
Premarket Approval (PMA) Submissions
Investigational Device Exemption (IDE) Applications
Breakthrough Device Designation & Safer Technologies Program (STeP) Support
Humanitarian Device Exemption (HDE) Applications
FDA Pre-Submission & Meeting Preparation
FDA Registration & Device Listing (eSTAR, FURLS)

Global Regulatory Submissions

EU MDR Technical File & CE Marking Submissions
UKCA Marking & MHRA Submissions
Health Canada Licensing Applications (MDL, MDEL)
Australia TGA Applications (ARTG Listing)
Japan PMDA Regulatory Support
China NMPA & Other International Market Approvals
ASEAN, LATAM, & Middle East Market Entry Strategies

Regulatory Compliance & Audit Support

FDA & Notified Body Inspection Readiness & Support
FDA 483 & Warning Letter Remediation Plans
EU MDR & IVDR Compliance Strategy & Implementation
MDSAP (Medical Device Single Audit Program) Preparation & Compliance
Post-Market Regulatory Compliance & Reporting
Adverse Event Reporting & Recall Management

Regulatory Documentation & Labeling Compliance

Regulatory Documentation Development & Gap Assessments
Labeling Compliance (UDI, FDA, EU MDR, GS1)
Instructions for Use (IFU) & Packaging Labeling Compliance (UDI, GUDID, EUDAMED, GS1, Global Labeling Standards)
Environmental & Biocompatibility Compliance (REACH, RoHS, WEEE)

Clinical & Post-Market Regulatory Support

Clinical Evaluation Reports (CER) & Literature Reviews (EU MDR)
Post-Market Surveillance (PMS) & Periodic Safety Update Reports (PSUR)
Post-Market Clinical Follow-Up (PMCF) Planning & Execution
Adverse Event & Vigilance Reporting (MDR, MedWatch, EUDAMED)
Medical Device Reporting (MDR) & Field Safety Corrective Actions (FSCA)

Software & Digital Health Regulatory Compliance

Software as a Medical Device (SaMD) & AI/ML Regulatory Pathways
FDA’s Predetermined Change Control Plan (PCCP) for AI-Based Devices
Cybersecurity & IEC 62304 Compliance for Software/Health IT
FDA’s Digital Health Policies & Compliance Support
Mobile Medical Apps & Connected Devices (IoT) Regulatory Review

Combination Products & Companion Diagnostics (CDx)

FDA & Global Regulatory Pathways for Combination Products
Drug/Device & Biologic/Device Combination Product Submissions
Companion Diagnostics (CDx) Regulatory Strategy & Approvals

Regulatory Change Management & Lifecycle Maintenance

Post-Approval Changes & Supplementary Filings (510(k) Modifications, PMA Supplements)
Change Control Documentation & Regulatory Impact Assessments
Global Market Expansion & Registration Maintenance

IVD

Quality Services

IVD

Regulatory Services

IVD Quality System Compliance & Certification

FDA Quality System Regulation (QSR), 21 CFR Part 820
ISO 13485:2016 for IVDs
ISO 15189:2022 (Medical Laboratories – Quality & Competence)
EU IVDR (In Vitro Diagnostic Regulation) Compliance
Medical Device Single Audit Program (MDSAP) for IVDs

IVD-Specific Quality Management System (QMS) Development

Design & Implementation of IVD-Specific QMS
QMS Transition from IVDD to IVDR
Internal & Supplier Audits for IVD QMS Compliance
Risk-Based Quality System Implementation

Validation & Process Control for IVDs

IVD Test Method Validation (TMV)
Analytical & Clinical Performance Validation
Software Validation (CSV) for IVD Software & LDTs
Process Validation (IQ, OQ, PQ) for IVD Manufacturing
Sterilization Validation & Biocompatibility Compliance for IVD Components
Environmental Control & Stability Testing Compliance

IVD Complaint Handling & Quality Risk Management

IVD-Specific Post-Market Surveillance (PMS) & Risk Mitigation
CAPA Implementation & Root Cause Analysis for IVD Failures
Failure Mode & Effects Analysis (FMEA) for IVD Risk Management
Risk-Based Approach to Quality for IVDs (ISO 14971 Compliance)

Regulatory Compliance Remediation & Audits

FDA 483, Warning Letter, & IVDR Noncompliance Remediation
IVD Internal & Supplier Audits for FDA, IVDR, ISO 13485, MDSAP Compliance
Notified Body Readiness Audits for IVDR Certification

IVD-Specific Labeling & UDI Compliance

IVD Unique Device Identification (UDI) Compliance (FDA GUDID, EUDAMED, GS1)
IVD Labeling Compliance (IFU, Package Inserts, Storage Conditions, Warnings)
Global Labeling Compliance (FDA, EU IVDR, Health Canada, TGA, NMPA, etc.)

Post-Market Surveillance & Field Action Management

IVD-Specific Complaint Handling & Adverse Event Reporting
Post-Market Performance Follow-Up (PMPF) for IVDR
Field Actions, Recalls, & Safety Notifications for IVDs
Periodic Quality Reviews & Trend Analysis

Regulatory Strategy & Market Access for IVDs

IVD Regulatory Strategy Development (U.S., EU, Canada, APAC, LATAM, etc.)
IVD Product Classification & Determination (FDA, EU IVDR, Health Canada, MHRA, TGA, PMDA, NMPA, etc.)
Companion Diagnostics (CDx) Regulatory Strategy & Approvals
Laboratory Developed Test (LDT) Compliance & Market Access
Pre-Submission (Q-Sub) Meetings with FDA for IVDs

U.S. FDA Regulatory Submissions for IVDs

510(k) & De Novo Submissions for IVDs
Premarket Approval (PMA) for High-Risk IVDs
Investigational Device Exemption (IDE) for Clinical Studies
Breakthrough Device Designation & Safer Technologies Program (STeP) for IVDs
FDA Registration & Listing (eSTAR, FURLS) for IVD Manufacturers

EU IVDR & Global IVD Market Approvals

EU IVDR Compliance & CE Marking for IVDs
IVDR Technical File Preparation & Notified Body Interactions
Performance Evaluation Reports (PERs) & Clinical Evidence Compliance
IVD Registration with Health Canada (MDL, MDEL)
IVD Approvals in TGA (ARTG Listing), NMPA (China), PMDA (Japan), & Other Markets

Regulatory Compliance & Audits for IVDs

IVDR Implementation & Notified Body Readiness Audits
FDA, Health Canada, MHRA, TGA, & Other Regulatory Inspection Readiness
ISO 20916 Compliance for IVD Clinical Performance Studies
Post-Market Surveillance (PMS) & Performance Follow-Up for IVDs
FDA 483, Warning Letter, & IVDR Noncompliance Remediation

Regulatory Documentation & Labeling Compliance

IVD-Specific Labeling & IFU Compliance (UDI, GUDID, EUDAMED, GS1, Global Labeling Standards)
Package Inserts & Labeling for Global IVD Compliance
Environmental & Biocompatibility Compliance (REACH, RoHS, WEEE)

Clinical & Post-Market Regulatory Support for IVDs

Clinical Performance Studies for IVDs (ISO 20916 Compliance)
Performance Evaluation Reports (PER) for IVDR Compliance
Post-Market Surveillance (PMS) & Periodic Safety Update Reports (PSUR) for IVDR
Post-Market Performance Follow-Up (PMPF) for IVDR
Medical Device Reporting (MDR) & Field Safety Corrective Actions (FSCA)

Software & Digital Health Regulatory Compliance for IVDs

Software as a Medical Device (SaMD) & IVD Software Compliance
FDA’s Predetermined Change Control Plan (PCCP) for AI-Based IVDs
Cybersecurity & IEC 62304 Compliance for Connected IVDs
FDA Digital Health Policies & Compliance for IVD Software
Mobile Medical Apps & Connected IVD Devices (IoT) Regulatory Review

Combination Products & Companion Diagnostics (CDx) for IVDs

Companion Diagnostics (CDx) Regulatory Strategy & Approvals
IVD-Drug & IVD-Biologic Combination Product Submissions
Companion Diagnostics (CDx) FDA & Global Market Approvals

Regulatory Change Management & Lifecycle Maintenance for IVDs

IVD Post-Approval Changes & Supplementary Filings
Change Control Documentation & Regulatory Impact Assessments
Regulatory Transition Support (IVDD to IVDR, PMA to De Novo, etc.)

PHARMACEUTICALS

Quality Services

PHARMACEUTICALS

Regulatory Services

Quality Management System (QMS) Services

cGMP Compliance (21 CFR Parts 210 & 211, ICH Q10)
EU GMP & PIC/S Compliance
ICH Q7 Compliance for API Manufacturing
Pharmaceutical QMS Implementation & Audits
Data Integrity Compliance (FDA, MHRA, ALCOA+ Principles)
MDSAP (Medical Device Single Audit Program) for Combination Products

Good Manufacturing Practices (GMP) Audits & Compliance

FDA & EMA GMP Readiness Audits
Mock FDA & MHRA Inspections
Supplier & Contract Manufacturer (CMO/CDMO) Audits
Quality Risk Management (ICH Q9)

Process & Product Quality Control

Pharmaceutical Process Validation (ICH Q8, Q11, Q12)
Analytical Method Development & Validation (ICH Q2)
Cleaning Validation & Environmental Monitoring Compliance
Sterilization Validation & Control for Aseptic Processing
Quality-by-Design (QbD) Implementation

Deviation Management, CAPA, & Root Cause Analysis

Deviation Investigations & GMP Non Conformance Handling
Corrective & Preventive Actions (CAPA) Implementation
Root Cause Analysis (RCA) for Manufacturing & Quality Issues
Change Control & Documentation Compliance (ICH Q12)

Quality Remediation & Compliance Support

FDA 483 & Warning Letter Remediation
CAPA Response & Quality System Remediation
Regulatory Compliance Gap Assessments
Recall & Market Withdrawal Support

Pharmaceutical Labeling & Packaging Compliance

FDA & Global Labeling Compliance (21 CFR 201, 211, 600, 801)
Serialization & Track-and-Trace (DSCSA, EU FMD, Global UDI)
Packaging Integrity Testing & Stability Compliance

Post-Market Quality & Safety Compliance

Pharmacovigilance Audits & Compliance (ICH E2E, EU GVP, FDA PV Guidance)
Adverse Event Reporting & Medical Complaint Management
Product Lifecycle Quality Management & Risk Mitigation

Regulatory Strategy & Market Access

Regulatory Strategy Development (FDA, EMA, MHRA, TGA, PMDA, NMPA, etc.)
Product Classification & Regulatory Pathway Determination
Orphan Drug Designation (ODD) & Fast Track Approvals
Breakthrough Therapy Designation & Expedited Programs
Regulatory Due Diligence for M&A & Licensing

U.S. FDA & Global Regulatory Submissions

IND (Investigational New Drug) & NDA (New Drug Application) Submissions
ANDA (Abbreviated New Drug Application) for Generics
505(b)(2) Regulatory Submissions & Hybrid Pathways
Biologics License Application (BLA) for Biopharmaceuticals
FDA Expedited Programs (Fast Track, Priority Review, Breakthrough Designation)

EMA, MHRA, & Global Regulatory Approvals

EMA Centralized, Decentralized, & National Procedures
EU Marketing Authorization Applications (MAA)
MHRA Approvals Post-Brexit & UK Regulatory Strategy
Regulatory Submissions for Japan (PMDA), China (NMPA), Canada (Health Canada), Australia (TGA), Brazil (ANVISA), etc.

Clinical Trial Regulatory Compliance

Clinical Trial Applications (CTA) & IND Submissions
Good Clinical Practice (GCP) Compliance (ICH E6, FDA 21 CFR Part 312)
Regulatory Oversight for Phase I-IV Trials
Pediatric Study Plans & Rare Disease Compliance (PREA, EU-PIP)

CMC (Chemistry, Manufacturing & Controls) Regulatory Support

CMC Section Preparation for IND, NDA, BLA, ANDA
Drug Substance & Drug Product Characterization Compliance
ICH Q3A/B Compliance for Impurities & Stability Studies
Regulatory Support for Tech Transfers & Scale-Up Approvals

Regulatory Labeling & Advertising Compliance

FDA & EMA Labeling Compliance (21 CFR 201, 202, PLR, EU SmPC)
DSCSA & EU Falsified Medicines Directive (FMD) Compliance
Drug Promotion & Advertising Compliance (FDA OPDP, PhRMA Code, FTC Regulations)

Post-Market Surveillance & Regulatory Maintenance

Periodic Safety Update Reports (PSURs) & Risk Management Plans (RMPs)
Pharmacovigilance Regulatory Compliance (FDA, EMA, ICH E2E)
Annual Reports, CMC Supplements, & Lifecycle Regulatory Maintenance
Field Action, Recalls, & Safety Communications with Health Authorities

Regulatory Compliance for Advanced Therapies & Biologics

Cell & Gene Therapy Regulatory Pathways (ATMPs, RMAT, EU ATMP)
Biosimilars Regulatory Approvals (FDA 351(k), EMA Biosimilar Pathway)
Companion Diagnostics (CDx) & Precision Medicine Regulatory Strategy
Personalized Medicine & Advanced Therapeutic Compliance

BIOLOGICS

Quality Services

BIOLOGICS

Regulatory Services

Quality Management System (QMS) Compliance

cGMP Compliance for Biologics (21 CFR Parts 600-680, ICH Q10)
FDA & EMA GMP Readiness Audits for Biologics Manufacturing
Biologic-Specific QMS Implementation & Maintenance
Data Integrity & Compliance (FDA, EMA, ALCOA+ Principles)
ICH Q7 Compliance for API & Biologic Drug Substance Manufacturing

Good Manufacturing Practices (GMP) for Biologics

Facility Design & Environmental Monitoring Compliance (ISO 14644, EU GMP Annex 1)
GMP Audits for Biologics Manufacturers & Contract Development and Manufacturing Organizations (CDMOs)
Vendor & Supplier Qualification for Raw Materials & Excipients
Cold Chain Logistics & Storage Compliance

Process & Product Quality Control for Biologics

Analytical Method Development & Validation (ICH Q2, USP 1225, Ph. Eur.)
Bioprocess Validation & Scale-Up Compliance (ICH Q8, Q11, Q12)
Sterilization & Aseptic Processing Compliance
Viral Clearance & Contamination Control Strategies
In-Process Controls & Batch Release Testing for Biologics

Deviation Management, CAPA, & Root Cause Analysis

Deviation Investigations & GMP Non Conformance Handling
Corrective & Preventive Actions (CAPA) Implementation
Root Cause Analysis (RCA) for Manufacturing & Quality Issues
Change Control Management for Biologics Manufacturing

Quality Remediation & Compliance Support

FDA 483 & Warning Letter Remediation for Biologic Manufacturers
Regulatory Compliance Gap Assessments for Biologics
Post-Approval Quality & Compliance Support
Recall & Market Withdrawal Support

Biologics Labeling & Packaging Compliance

FDA & Global Labeling Compliance (21 CFR 610, 801, 211)
Serialization & Track-and-Trace (DSCSA, EU FMD, UDI Compliance for Combination Products)
Packaging Integrity & Stability Compliance (ICH Q1A, Q5C)

Post-Market Quality & Safety Compliance for Biologics

Biologic Product Complaint Handling & Investigations
Risk-Based Quality Audits & Post-Market Surveillance Compliance
Adverse Event & Pharmacovigilance Compliance (ICH E2E, FDA, EMA, WHO GVP)
Biologic Product Lifecycle Quality Management

Regulatory Strategy & Market Access

Biologic Product Regulatory Strategy Development (FDA, EMA, PMDA, NMPA, etc.)
Regulatory Pathway Determination (BLA, IND, Fast Track, RMAT, Breakthrough Therapy, Orphan Drug Designation, etc.)
Expedited Programs for Biologics (Fast Track, Priority Review, RMAT, Breakthrough Designation)
Regulatory Due Diligence for Biologic M&A & Licensing

U.S. FDA & Global Regulatory Submissions for Biologics

Investigational New Drug (IND) Applications for Biologics
Biologics License Applications (BLA) & Supplements
FDA RMAT (Regenerative Medicine Advanced Therapy) Designation
Orphan Drug Designation (ODD) for Biologic Therapies
505(b)(2) Regulatory Pathways for Biologic Reformulations & Follow-ons

EMA, MHRA, & Global Regulatory Approvals

EMA Marketing Authorization Applications (MAA) for Biologics
EU Centralized Procedure for Biologics Approval
MHRA Biologics Approvals & UK Market Entry Strategy
Global Regulatory Submissions (PMDA, NMPA, Health Canada, TGA, ANVISA, etc.)

Clinical Trial Regulatory Compliance for Biologics

Clinical Trial Applications (CTA) for Biologics & ATMPs
Good Clinical Practice (GCP) Compliance (ICH E6, FDA 21 CFR Part 312)
Cell & Gene Therapy-Specific Clinical Trial Regulatory Support
Pediatric Study Plans & Rare Disease Compliance (PREA, EU-PIP)

CMC (Chemistry, Manufacturing & Controls) Regulatory Support for Biologics

CMC Section Preparation for IND, BLA, and Post-Approval Changes
Biologic Drug Substance & Drug Product Characterization Compliance
ICH Q5A/B Compliance for Stability & Viral Safety Studies
Regulatory Oversight for Tech Transfers & Scale-Up Approvals
Advanced Manufacturing Technologies for Biologics (e.g., Continuous Manufacturing, Single-Use Systems)

Regulatory Labeling & Advertising Compliance

FDA & EMA Biologics Labeling Compliance (21 CFR 610, PLR, EU SmPC)
Advertising & Promotion Review for Biologics (FDA OPDP, EMA, FTC, PhRMA Code)
DSCSA & EU Falsified Medicines Directive (FMD) Compliance for Biologic Serialization

Post-Market Regulatory Compliance & Lifecycle Management

Periodic Safety Update Reports (PSURs) & Risk Management Plans (RMPs) for Biologics
Biologics Pharmacovigilance Compliance (FDA, EMA, ICH E2E)
Annual Reports, CMC Supplements, & Lifecycle Regulatory Maintenance for Biologics
Field Action, Recalls, & Safety Communications with Health Authorities

Regulatory Compliance for Advanced Therapies & Biosimilars

Cell & Gene Therapy Regulatory Pathways (FDA RMAT, EU ATMP, Japan PMDA, China NMPA, etc.)
Biosimilars Regulatory Approvals (FDA 351(k), EMA Biosimilar Pathway, WHO Guidelines)
Companion Diagnostics (CDx) & Precision Medicine Regulatory Strategy
Personalized Medicine & Advanced Therapeutic Compliance

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Let’s talk about how PRP Compliance can support your regulatory and quality compliance needs. Reach out today and connect with our team—we’re here to help you move forward with confidence.