Pharmaceuticals

Navigating Regulatory Complexity. Enabling Market Access. Ensuring Compliance.

At MCS Associates, we simplify the path to regulatory approval for pharmaceutical, biologic, natural health, and medical device products in Canada and the United States. Whether you are registering a prescription drug requiring a Canadian Drug Identification Number (DIN) or preparing a U.S. FDA submission, we provide end-to-end regulatory support grounded in quality, compliance, and real-world experience.

Canadian Drug Registration

Your Trusted Partner for DIN Applications

To legally market a prescription or over-the-counter drug in Canada, a valid Drug Identification Number (DIN) issued by Health Canada is mandatory. Our regulatory consultants offer expert guidance through every stage of the DIN application process:

• Product Classification & Regulatory Pathway Determination
• Preparation of Drug Submission (NDS, SNDS, ANDS)
• Label Compliance Review & Mock-up Preparation
• Response Management to Health Canada Queries
• Post-market Amendments & Maintenance

With a deep understanding of Canadian regulatory frameworks and standards for Good Manufacturing Practices (GMP), we ensure your submission aligns with Health Canada’s evolving expectations. Like Innomar Strategies and CanReg, we integrate regulatory knowledge with operational excellence—delivering compliant, timely, and commercially viable outcomes.

U.S. Drug Registration & FDA Liaison

From 505(b)(2) to ANDA: Streamlined U.S. FDA Submissions

Accessing the U.S. market requires navigating a highly structured regulatory landscape. We help Canadian and international clients prepare robust submissions for the U.S. Food and Drug Administration (FDA), including:

• Drug Master File (DMF) Preparation & Filing
• NDA, ANDA, and 505(b)(2) Applications
• OTC Monograph Compliance
• Establishment Registration & SPL Labeling
• FDA Agent Representation for Foreign Manufacturers

Our team aligns regulatory strategy with your commercial objectives, helping you avoid costly delays and ensuring long-term compliance in the U.S. marketplace.

Quality & Compliance Are Not Buzzwords—They’re Our Foundation

Drawing inspiration from industry leaders like Innomar and CanReg, our approach to regulatory affairs is rooted in quality systems thinking. We don’t just submit paperwork—we build compliance into your entire product lifecycle, ensuring your operations remain audit-ready from dossier preparation to post-market pharmacovigilance.

• GMP & GPP Readiness Assessments
• Standard Operating Procedure (SOP) Development
• Label & Package Compliance Audits
• Regulatory Gap Analyses & Risk Mitigation Planning

Whether you’re a start-up navigating your first DIN submission or a global firm optimizing cross-border filings, we act as your regulatory extension—providing personalized service, strategic foresight, and measurable results.

Start Your Product Journey with Confidence.

Ready to bring your product to the Canadian or U.S. market? Contact our Regulatory Affairs team for a confidential consultation and discover how we can help you achieve approval faster—with integrity and impact.

We can support your entire registration process, from initial submission preparation right through to the review process, as one of the most experienced CGMP pharmaceutical Regulatory Affairs consulting GMP Audit Services companies in Canada. We routinely handle your CGMP pharmaceutical submissions with Health Canada, whether your product requires a label review, amendment, or a brand new submission.

Timely approvals, in part, require having the right CGMP pharmaceutical team on your side that understands the issues that impact the review of new drug submissions. You need a team that remains current with evolving regulations both in terms of regulatory developments but also chemical developments and many allied fields. This is important in that these changes may impact the development and approval of your products, as well as changes to the regulatory landscape that will challenge tour efforts.

As one of the most experienced GMP Audit Companies, our committed expert regulatory affairs professionals bring extensive experience when it comes to assessing your operations. Our GMP Audit Services encompass comprehensive system reviews that highlight gaps in your pharmaceutical quality management system. As a responsible, full-service GMP audit company we also provide pragmatic solutions for any identified gaps – this way you are not left with just a list of recommendations but a certain pathway forward. Finally, as an integral part of our GMP audit services, the experts at MCS are also available to implement solutions rapidly and effectively. The goal of any implemented solution is sustainability – and this is embodied in our GMP Audit Services philosophy.

GMP audit services are essential supportive services for the preparation and filing of the following pharmaceutical regulatory submissions. We prepare and file the following pharmaceutical regulatory submissions:

New Drug Submissions (NDS)

Our Regulatory Affairs consulting experts have experience with NDS application packets. New Drug Submissions with Health Canada for brand-name patented drugs include preparation and filing of scientific information about product safety, efficacy, and quality, claimed therapeutic value, conditions for use and side effects, results of pre-clinical and clinical studies, production details, packaging, and labeling information.

Abbreviated NDS (ANDS) for generic drugs

The ANDS submission involves submitting data that shows how the generic product performs when compared with the brand-name product.  It must be shown to be as safe and efficacious as the brand-name product and must meet the same quality standards as an NDS; that is why when working with GMP Audit companies in Canada, we identify and correct non-conformities or deviations that could affect the product quality or safety. Submission includes scientific information, production details, packaging and labeling, and comparative bioavailability studies showing how the generic drug can deliver the same amount of medicinal ingredient at the same rate as the brand-name product.

Supplemental NDS (SNDS) for already-authorized drug products

Includes changes to dosage form or strength, formulation, manufacturing method, labeling, recommended route of administration or to expand the claims or conditions of use (indications). Our expert Regulatory Affairs consultants ensure that all modifications are thoroughly reviewed and compliant.

Drug Identification Number (DIN)

Our team prepares and submits applications for Drug Identification Numbers for products in Canada that do not meet the definition of a ‘new drug’ also.

Pharmaceutical Drugs Directorate (PDD)

The Pharmaceutical Drugs Directorate in Canada is the agency that reviews the DIN application. An acceptable label design is required to show the PDD that the product is not going to be marketed in a manner that is false, misleading, or deceptive or is likely to create an erroneous impression regarding its character, efficacy, quantity, composition, or safety. The comprehensive and in depth GMP Audit services offered by our firm confirm your product’s readiness for market.

Audits

Why the Pharmaceutical Industry Needs Third-Party cGMP Audits

In today’s globalized and highly regulated landscape, Good Manufacturing Practice (cGMP) compliance is no longer optional—it is a legal, ethical, and business imperative. But internal audits alone are not enough to meet the expectations of regulators, partners, and the public. That’s where third-party cGMP audits come in.

At MCS Associates, we serve as your independent eyes and ears—offering unbiased, expert-led audits that help you identify risk, ensure supplier compliance, and maintain the integrity of your pharmaceutical quality system.

Why MCS Associates is the Trusted Choice for cGMP Audits

MCS Associates brings decades of frontline experience in pharmaceutical quality, compliance, and regulatory affairs. We provide clients with risk-based, inspection-ready audits that are practical, professional, and globally recognized.

Here’s why top pharmaceutical companies choose MCS:

• Industry-Specific GMP Expertise
  Our auditors specialize in cGMP regulations across APIs, finished dosage forms, sterile products, biologics, and more—ensuring our audits are relevant, rigorous, and compliant with 21 CFR Parts 210/211, ICH Q10, and Health Canada GMP.
• Unbiased, Third-Party Objectivity
  As a neutral third party, we deliver audit results you can trust—with no internal conflicts of interest and no hidden agendas.
• Global Regulatory Alignment
  We audit to FDA, Health Canada, EU GMP, PIC/S, and WHO GMP standards. Whether your market is North America, Europe, or beyond, we ensure your operations meet international expectations.
• Actionable, Risk-Based Reporting
  Our audit reports are clear, prioritized, and CAPA-ready—providing your team with a roadmap for compliance and continuous improvement.
• From Supplier Audits to Full GMP Remediation
  Whether you need a one-time vendor audit or a full GMP remediation audit following regulatory action, we scale our services to your needs.

GMP Audits for the Pharmaceutical Industry

• Health Canada GMP Guidelines for Pharmaceuticals, NHPs, and Cosmetics
• U.S. FDA Regulations (21 CFR Parts 210/211, 111, 820, 117)
• To ensure compliance in the pharmaceutical industry, audits must be conducted against globally recognized, regulatory and quality standards that address every stage of the product lifecycle—from raw material sourcing to distribution. Below are the key audit criteria that form the backbone of compliance-focused pharmaceutical audits:

1. Current Good Manufacturing Practices (cGMP)

• Regulatory Frameworks:
  • U.S. FDA – 21 CFR Parts 210 and 211
  • Health Canada – Good Manufacturing Practices (GUI-0001)
  • EU EMA – EU GMP Annexes
  • WHO GMP – For global benchmarking
  • PIC/S GMP – Harmonized for international consistency
• Audit Criteria Include:
  • Quality systems and documentation
  • Premises and equipment cleanliness and suitability
  • Manufacturing and packaging processes
  • Personnel training and hygiene
  • Validation and qualification (process, cleaning, equipment)
  • Change control and deviation management
  • Complaint and recall procedures

2. Quality Management System (QMS)

• Referenced Standards:
  • ICH Q10 – Pharmaceutical Quality System
  • ISO 9001:2015 – Quality Management Systems – Requirements
  • ISO 13485 – (Medical Devices, but increasingly referenced for pharma-adjacent technologies)
• Audit Criteria Include:
  • Document control and records management
  • Internal audit programs
  • Risk management and mitigation strategies
  • Corrective and Preventive Actions (CAPA)
  • Quality objectives and performance metrics
  • Management review and continuous improvement

3. Data Integrity and Electronic Systems Compliance

• Referenced Standards:
  • FDA 21 CFR Part 11 – Electronic records and signatures
  • EU GMP Annex 11 – Computerized systems
  • MHRA GxP Data Integrity Guidance
  • GAMP 5 – Good Automated Manufacturing Practice
• Audit Criteria Include:
  • ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
  • Access control and user authentication
  • Audit trails and system validations
  • Backup, archival, and disaster recovery systems
  • Validation of software, LIMS, and MES platforms

4. Supplier and Vendor Qualification

• Relevant References:
  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • ISO 17025 – Testing & Calibration Laboratories
  • Health Canada GUI-0061 – Guidance on Outsourced Activities
  • Audit Criteria Include:
  • Qualification and requalification processes
  • Technical and quality agreements
  • Supply chain traceability
  • Performance and deviation history
  • On-site inspections and quality audits

5. Product Lifecycle and Risk Management

• Relevant Guidelines:
  • ICH Q8 (R2) – Pharmaceutical Development
  • ICH Q9 – Quality Risk Management
  • ICH Q11 – Development & Manufacture of Drug Substances
• Audit Criteria Include:
  • Integration of Quality by Design (QbD) principles
  • Risk assessment tools (e.g., FMEA, HACCP)
  • Continuous Process Verification (CPV)
  • Technology transfer documentation
  • Product complaints and pharmacovigilance (if applicable)

6. Global Trade, Import, and Distribution Compliance

• Referenced Guidelines:
  • GDP Guidelines (Good Distribution Practices)
  • Health Canada and FDA Import Compliance
  • Serialization and Track & Trace Regulations (e.g., DSCSA in the U.S., EU FMD)
• Audit Criteria Include:
  • Cold chain and controlled substance handling
  • Packaging integrity and labeling controls
  • Serialization and anti-counterfeiting systems
  • Broker and third-party logistics compliance

A compliant pharmaceutical audit program must be built on a foundation of globally harmonized criteria, with attention to evolving regulations, data governance, and risk-based quality systems. Firms like MCS Associates are uniquely positioned to audit against this complex matrix—ensuring clients meet not just the letter, but the spirit of global compliance.