Regulatory Services

Regulatory Services

Regulatory Strategy & Market Access

CMC Authoring and Publishing

Quality System & Good Manufacturing Practices

Post Market Compliance Services

Clinical Services & Regulatory Support

Regulatory Strategy & Market Access

At Propharmex, we support your product from concept to commercialization by crafting robust regulatory strategies and ensuring seamless market access in compliance with Canadian and Global regulations. Our team of experienced regulatory professionals specializes in aligning product development with Health Authorities evolving requirements, helping you minimize delays and maximize success.

Product Classification and Regulatory Pathway Determination
Due Diligence and Regulatory Feasibility Assessments
Labeling Compliance and Regulatory Review
Regulatory Intelligence and Lifecycle Planning
Consultation Support with Health Authority

CMC Authoring and Publishing

At Propharmex, we recognize and understand scientific and regulatory complexity behind pharmaceutical products and regulatory requirements. Our team streamlines data based on the regulatory pathway and jurisdiction to ensure clarity, compliance, and accuracy.

We specialize in high-quality CMC authoring and regulatory strategy by following robust documentation standards and a meticulous review process from early Product development stages to market access and support entire product lifecycle, providing end-to-end regulatory solutions that accelerate your path to market (With successful track record of obtaining Health Canada approvals in a short span of 6 – 9 months). We tailor data presentation to suit the product type and application requirements ensuring accuracy, compliance and efficiency.

Our expertise spans a broad spectrum of product types including: Active Pharmaceutical Ingredients (APIs), Biologics and biosimilars, Complex molecules, Small molecules, Medical Devices, Natural Health Products and Over The Counter (OTC).

Regulatory Publishing

Propharmex remains fully aligned with all current Health Canada guidelines and Global regulatory requirements to ensure efficient and timely product approvals.

We operate using the electronic Common Technical Document (eCTD) format across a wide range of submission types supporting major markets through CESG gateway (US, Europe, Canada, Australia & South Africa), NeeS, country-specific dossier submission and ASEAN Common Technical Dossier (ACTD) formats

Quality System & Good Manufacturing Practices

At Propharmex, we provide end-to-end Quality and Good Manufacturing Practices (GMP) support tailored to pharmaceutical, biologics, natural health products (NHPs), and medical device industries. Our team of regulatory and quality experts ensures your operations meet Health Canada, FDA, EMA, and international GMP standards to facilitate timely market access and maintain product integrity.

Propharmex played a pivotal role in establishing and managing regulatory affairs and quality assurance systems for international companies expanding into Canada. To date, Propharmex has guided several organizations through successful acquisition of Drug Establishment Licences (DELs), while also supporting GMP audit readiness and direct Health Canada inspections for Canadian facilities.

Our Comprehensive GMP & Quality Services Include:

Validation Protocols & Reports
Manufacturing Process & Cleaning Support
Analytical & Laboratory Services
MDEL & DEL Licensing (Canada)
GMP Compliance & Inspection Readiness
Vendor Qualification & Audit Support
Regulatory & Quality Consulting

Our experienced consultants serve as an extension of your QA/RA teams to provide: Quality system design and implementation, Lifecycle GMP consulting for clinical to commercial stages, QMS audit remediation strategies, Support for responding to regulatory observations (e.g., Health Canada IRs, FDA 483s).

Propharmex has a strategic alliance with a Canadian pharmaceutical warehouse and healthcare logistics provider, offering clients a seamless one-stop shopping for all regulatory and compliance requirements

Post Market Compliance Services

Maintaining regulatory compliance after product launch is critical to ensuring continued market access and upholding consumer safety. At Propharmex, we provide comprehensive post-market compliance solutions tailored to help companies navigate evolving regulatory requirements with confidence.

Our Post-Market Services Include:

Product License Renewals and Variation Filings
Annual Drug Notification Filing
Importation Compliance for Foreign Manufacturers
Recall Management Support
Regulatory Label Updates

Clinical services & Regulatory support

At Propharmex, we extend our regulatory expertise into the clinical domain by providing end-to-end scientific and regulatory support for clinical studies, specifically tailored to meet Health Canada and Global requirements. Our team works closely with clients to ensure clinical documentation is scientifically robust, regulatory-compliant, and strategically positioned for approval.

Our Clinical Services Include:

Protocol Development & Review
Bioequivalence (BE) Study Design and Review
Analytical & Bioanalytical Validation Review
Scientific Consultation for Clinical Submissions

We provide strategic scientific guidance throughout the clinical phase, helping sponsors respond effectively to Global Health Authority queries during the review process. Our support includes crafting scientifically sound justifications, data explanations, and additional information requests, helping to accelerate the review timeline.

Whether you are preparing for initial clinical submissions or responding to submission queries, Propharmex is your trusted partner in navigating the complexities of clinical and regulatory integration.

Partner with us to address your specific needs and achieve your strategic business goals

Your vision, our expertise. driving results that matter