At Pharmareg Consultancy, we offer a wide range of regulatory consulting services, designed to address the challenges pharmaceutical companies face and to help businesses succeed in this highly regulated environment. Our services span across
- human medicines
- veterinary medicines
- medical devices and cosmetics
Product Registration & Licensing
Navigating the product registration process can be complex, but Pharmareg Consultancy ensures seamless regulatory approval for your products. Our services include:
- CTD/eCTD Dossier Preparation – We ensure full compliance with regulatory guidelines for efficient dossier compilation and submission.
- Regulatory Strategy & Gap Analysis – Our experts identify potential hurdles early, optimizing your submission strategy for faster approvals.
- Submission & Agency Liaison – We manage all interactions with health authorities, streamlining the approval process.
- Lifecycle Management – From variations and renewals to compliance updates, we support your product at every stage.
Regulatory Inspections & Compliance
Our team prepares you for rigorous regulatory inspections, ensuring your business remains audit ready and compliant with GxP standards:
- Audit Preparation – We assist in preparing your organization for successful inspections and provide mock audits to assess compliance.
- Inspection Hosting & Response Management – We guide you through the entire inspection process and support corrective actions as needed. We assist in responding to inspection findings and implementing corrective actions.
- Ongoing Regulatory Monitoring – Stay ahead of changing regulations with continuous updates and compliance checks.
Import & Export (IMPEX) Regulatory Support
Successfully navigating global trade compliance is vital for market expansion. Pharmareg Consultancy offers the following services:
- Import/Export Permits & Licensing – We ensure compliance with regulatory requirements and fast-track permit approvals, ensuring smooth entry of your products into new markets.
- Customs & Border Compliance – Our team ensures full adherence to international trade laws, mitigating potential risks.
- Regulatory Documentation & Legal Requirements – We help you meet all trade compliance needs, reducing the risk of regulatory delays or penalties.
Clinical Trials (CT) & Ethics Approvals
Clinical trials require meticulous regulatory oversight to ensure compliance and safety. Our services include:
- Regulatory Support for Clinical Trial Applications (CTAs) – We guide you through the application process, ensuring all regulatory requirements are met.
- Ethics & Regulatory Board Approvals – We facilitate and expedite the approval process by liaising with ethics committees and regulatory authorities.
- Safety Reporting & Pharmacovigilance in Trials – We ensure proper adverse event reporting and compliance with global safety standards during trials.
- Site & Investigator Compliance – We provide training and audits to ensure trial sites and investigators adhere to regulatory and ethical standards.
Pharmacovigilance & Safety Monitoring
Pharmareg Consultancy helps you maintain the safety and efficacy of your products after they hit the market:
- Adverse Event Reporting & Risk Management – We help you establish systems to track and report adverse events, through creation and monitoring of plans to manage product risks and ensure patient safety.
- Pharmacovigilance System Setup – We establish global-standard drug safety frameworks for monitoring product safety post-market.
- Periodic Safety Update Reports (PSURs) – We develop and manage PSURs, conducting risk-benefit analyses and ensuring ongoing safety compliance in order to keep regulatory authorities informed.
Post-Marketing Surveillance (PMS)
Long-term product safety is critical, and our PMS services provide continuous oversight of your products in the market:
- Market Surveillance & Trend Analysis – We track market trends to identify safety signals and compliance gaps early.
- Product Complaint Handling & Recall Management – We help you implement risk mitigation strategies to manage product complaints and recalls effectively.
- Regulatory Reporting & Compliance Updates – Our team ensures your product remains aligned with evolving regulatory requirements post-launch.
Quality Management Systems (QMS) Implementation & Audits
Ensuring consistent quality and regulatory compliance is at the heart of our QMS services:
- QMS Development & Implementation – We design quality management systems that align with ISO 9001, WHO-GMP, GDP, GCP, and ICH guidelines.
- Internal & Supplier Audits – Our audits ensure that your supply chain is fully compliant with GMP, GDP, and ISO standards, i.e., we ensure your operations meet ISO and regulatory standards.
- Quality Risk Management (QRM) – We proactively identify and mitigate compliance risks, enhancing your operational efficiency.
- Standard Operating Procedures (SOPs) & Training – We develop and facilitate implementation of SOPs, training programs and other compliance documentation to ensure your team upholds regulatory excellence.
Our Service Offering
Thank you for your interest! Please feel free to reach out to us using the contact details provided or by completing the form on the right. For expert registration assistance or any customer service inquiries, kindly utilize the dedicated buttons below.