Pharmaceuticals & Biotech in 100+ countries

Pattern of USA Inc. is consistently engaged in projects encompassing:

Regulatory Affairs and Compliance

Quality Assurance in Regulatory Surveillance

Uninterrupted Supply Chain Security

Cost Efficiency in Regulatory Projects

Innovation and Research Compliance

Global Market Access and Business Development

Current Patient Safety Requirements

Adaptability to Emerging Technologies

Sustainability and Adherence to Post-Marketing Prerequisites

Browse Simplified Regulatory Affairs Roadmaps below

Discover the Benefits of Choosing Pattern of USA Inc. as End-To-End Provider

As a prominent global Regulatory Affairs Solutions and Services Provider, Pattern of USA Inc. offers invaluable assistance to a wide range of Life Sciences companies, from startups to small, mid-sized, and large corporations, as well as major players in the global Life Science industry. Our team comprises regulatory professionals, including former officers from National Regulatory Authorities (NRAs/NCA), possessing extensive knowledge of current requirements and compliance standards.

In the dynamic landscape of global health authorities, Regulatory Affairs services play a pivotal role in ensuring the successful development and commercialization of products. Compliance throughout this intricate and ever-evolving process is a mandatory prerequisite. To navigate the complexities across the product life cycle, organizations turn to proven experts for Regulatory Affairs consulting. Our expert team acts as a vital link between organizations and National Regulatory Authorities, diligently tracking all key regulations related to the product and the prerequisites for its launch.

As a specialized global Regulatory Affairs Consulting partner, Pattern of USA Inc. serves as a bridge between organizations and key NRAs/NCAs, including, but not limited to:

– U.S. FDA (Food and Drug Administration) – United States

– EMA (European Medicines Agency) – European Union

– MHRA (Medicines and Healthcare products Regulatory Agency) – United Kingdom

– PMDA (Pharmaceuticals and Medical Devices Agency) – Japan

– Health Canada – Canada

– TGA (Therapeutic Goods Administration) – Australia

– ANVISA (National Health Surveillance Agency) – Brazil

– CFDA (China Food and Drug Administration) – China

– KFDA (Korea Food and Drug Administration) – South Korea

– SFDA (Saudi Food and Drug Authority) – Saudi Arabia

Pattern of USA Inc. stands out as a leading Regulatory Affairs services company, pioneering the provision of strategic multidisciplinary Regulatory Affairs consulting services globally. Our comprehensive Regulatory Affairs services cover the entire spectrum of product development, registration, and commercialization.

Pattern of USA Inc. global Regulatory Affairs services consultants empower Life Science companies to comprehend and effectively manage the intricate complexity of diverse Regulatory requirements. This enables them to successfully launch their products in new markets and maximize market value. Our expertise spans Regulatory Strategy, Regulatory Intelligence, On-time Submissions for Market Authorization, Post-Approval Product Maintenance, and other related functions.

Prep Activities

Regulatory Intelligence: Constant monitoring and analysis of regulatory changes to ensure compliance and strategic planning.
Intellectual Property Rights Protection: Vigilant safeguarding of intellectual property rights through proactive strategies.
Regulatory Compliance and Gap Analysis: Thorough assessment and rectification of compliance gaps to mitigate risks.
Pre-Sub Activities: Strategic planning and preparation for successful submissions.
Authorized Representative: Comprehensive support as EU AR & US Agent, ensuring smooth regulatory processes.
NRA Classification: Expert classification services for National Regulatory Authorities.
GMP Pre-Audit: Pre-audit assessments to ensure Good Manufacturing Practices compliance.
GCP Pre-Audit: Rigorous pre-audit evaluations for Good Clinical Practices adherence.
GLP Pre-Audit: Detailed pre-audits to uphold Good Laboratory Practices standards.
GDP Pre-Audit: Comprehensive evaluations to ensure compliance with Good Distribution Practices.
GVP Pre-Audit: Thorough pre-audits to uphold Good Pharmacovigilance Practices.
CRO Monitoring: Proactive oversight and monitoring of Contract Research Organizations to maintain quality standards.

Submission Activities

IND Application Support: Expert guidance and assistance throughout the Investigational New Drug (IND) application.
New Drug Applications (NDA):
- Innovative Drug (Novel NDA): Tailored services for novel drug submissions.
- Improved Drug (NDA): Assistance with submissions for improved drugs.
Generic Drug Applications (ANDA): Comprehensive support for Abbreviated New Drug Application submissions.
Variation Notifications:
- Type IA and IA-IN: Efficient handling of Type IA and IA-IN variation notifications.
- Type IB: Expert management of Type IB variation notifications.
- Type II: Facilitation of Type II variation approvals.
Line Extension: Assistance with Marketing Authorization (MA) line extension submissions.
EU-M4all Procedure: Guidance through the EU-M4all procedure for marketing authorization.
MA Renewal: Support for Marketing Authorization renewal processes.
FDA Establishment Services:
- Registration: Assistance with FDA Establishment Registration.
- Recognition: Facilitation of FDA Establishment Recognition.
- Inspection: Guidance and support for FDA Establishment Inspections.
GMP Compliance:
- Recognition: Verification for Good Manufacturing Practice (GMP) certification.
- Inspection: Support for GMP inspections and certification.

Post-Market Activities

Ongoing Pharmacovigilance Service: Continuous monitoring and reporting of adverse events to ensure product safety and compliance with regulatory requirements.
Post-Authorization Efficacy Study (PAES): Assistance in conducting and managing post-authorization efficacy studies to evaluate the real-world effectiveness of products.
Post-Authorization Measures (PAMs): Support in implementing and monitoring post-authorization measures as mandated by regulatory authorities.
Preparation and Submission of PSUR (Periodic Safety Update Report): Assistance in compiling and submitting PSURs to regulatory agencies to provide updates on the safety profile of products.
Single Assessment PSUR Development and Submission: Guidance and support in preparing and submitting PSURs through the EU single assessment process for streamlined regulatory compliance.
Annual Compliance Update: Provision of annual updates to ensure ongoing compliance with regulatory standards and requirements.

Selected Add-Ons

Commercial Ad, Labeling, and Health Claims Compliance Check: Thorough review and validation of commercial advertisements, labeling, and health claims for regulatory compliance.
Product Launch Support: Comprehensive assistance to ensure a smooth and successful launch of pharmaceutical and biotech products into the market.
Randomized Labeling for CRO: Customized labeling solutions for Contract Research Organizations (CROs) to meet specific study requirements.
Non-clinical Data SEND Conversion: Expert conversion of non-clinical data into the Standard for Exchange of Nonclinical Data (SEND) format for regulatory submission.
CARES Act Reporting: Assistance with compliance reporting under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
RMPs and aRMM Development (EU): Development of Risk Management Plans (RMPs) and additional Risk Minimization Measures (aRMM) to ensure product safety and efficacy in the EU market.
REMS and ETASU Development (US): Design and implementation of Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU) in the US market.
MA Transfer: Smooth transition of Marketing Authorization (MA) from one entity to another, ensuring regulatory compliance throughout the transfer process.
Sunset Clause and MA Closing Activity: Management of Sunset Clause obligations and activities related to Marketing Authorization (MA) closure.