What is Regulatory Affairs?
Last updated on: September, 2024
The pharmaceutical industry is one of the most heavily regulated, and Regulatory affairs experts help ensure the quality, safety, and efficacy of medicines. Regulatory affairs is an integral part of the lifecycle of medicinal products. From drug discovery and development, through initial commercialization, and throughout the product’s lifecycle, Regulatory professionals help to navigate the complex and ever-changing landscape of global health authority requirements, maintaining Regulatory compliance at all stages.
Pharmaceutical Regulatory affairs professionals, such as those at Freyr, maintain a key communication link between pharmaceutical companies and Regulatory authorities across the globe.
By ensuring compliance with Regulatory standards and adapting to policy changes, companies can achieve their aim of bringing safe and effective products to market.
What is the purpose of Regulation in the Pharma industry?
Government regulation plays a crucial role in the pharmaceutical industry, primarily to safeguard public health by ensuring that new drugs are both safe and effective before they reach the market and continue to be so when on the market. Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, enforce rigorous standards that pharmaceutical companies must meet. These standards include requirements for comprehensive testing and evaluation of new and existing drugs, and while this can extend the development timeline, it is essential to help minimize potential risks to health, and to provide confidence in medical treatments available to the public.
In the European Union, the European Medicines Agency (EMA) and the various National Health Authorities perform a similar function, overseeing the evaluation and supervision of medicinal products. In Australia, regulation is provided by the Therapeutic Goods Administration (TGA). The TGA regulates therapeutic goods including medicines and medical devices, while the Medicines and Healthcare Products Regulatory Agency (MHRA) serves this role in the United Kingdom. South Africa's Regulatory body is the Medicines Control Council (MCC), which ensures and regulates the safety, quality, and efficacy of medicines.
These and other Regulatory bodies are tasked with balancing the need for access to new treatments and minimising potential risks to patients. They also play a role in monitoring drugs post-approval to help ensure ongoing safety. The collaboration between pharmaceutical companies and Regulatory agencies is vital to advancing healthcare and protecting the well-being of patients across the globe.
What is the role of Regulatory Affairs Professionals?
Regulatory Affairs (RA) professionals play a critical role in the pharmaceutical industry by ensuring that products are developed, manufactured, and controlled in compliance with Regulatory standards to help assure their quality, safety, and efficacy. Regulatory professionals are integral throughout a drug product's lifecycle. Their involvement begins with:
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Clinical Phase
Design and execution of clinical trials to test safety and efficacy, with Regulatory oversight on documentation and compliance.
During the clinical phase, Regulatory professionals play a crucial role in developing the right clinical development strategy, helping to ensure that clinical trials are designed and conducted in compliance with Regulatory requirements. They also prepare and submit the necessary documentation, such as the Investigational Medicinal Product Dossier (IMPD), to Regulatory authorities.
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Marketing Approval and Authorization
Submission of a detailed dossier for Regulatory review to obtain permission to market the drug.
In the marketing approval and authorization phase, Regulatory professionals compile and submit a comprehensive dossier in the Common Technical Document (CTD) format to Regulatory authorities. They ensure that the dossier meets all the necessary quality, safety, and efficacy standards for the product to be approved for marketing.
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Commercialization
Management of the marketed product, including post-approval changes, Regulatory compliance, and adherence to Regulatory standards.
Once a marketing authorization is granted, Regulatory professionals continue to manage post-approval changes, such as variations and other updates to the approved dossier. They help ensure ongoing compliance with Regulatory requirements and facilitate any necessary changes to the product or its manufacturing process.
Regulatory Affairs (RA) professionals, such as those at Freyr, can provide Regulatory support in all phases of drug development, from maintaining compliance with Regulatory requirements to marketing authorization Holder Support (MAH) and post-approval lifecycle management.
What are the risks of Regulatory non-compliance in Pharma?
Pharmaceutical firms can face significant consequences if they do not meet Regulatory standards including hefty fines, litigation, and delayed approvals. Non compliance may lead to product withdrawals, damaging both sales and reputation. In addition, they may be subject to heightened Regulatory scrutiny and costly product recalls.
Regulatory non-compliance is one of the most serious challenges for the pharmaceutical sector, and it can have severe repercussions for a company. These include:
- Financial Penalties and Legal Action: Companies may face substantial fines and penalties for failing to comply with Regulatory requirements. Regulatory non compliance can lead to legal action against the company, including lawsuits and criminal charges.
- Delays in Drug Approval and Market Withdrawal: Non-compliance can result in delays in obtaining marketing authorizations, which can significantly impact a company's ability to commercialize its products and generate revenue. In cases of serious non compliance, a product may be withdrawn from the market, leading to loss of sales and potential damage to the company's reputation.
- Reputational Damage: The impact of non-compliance on a company’s reputation can be long-lasting and can affect its relationships with stakeholders, including investors, healthcare professionals, and patients.
- Increased Scrutiny: A history of non-compliance can lead to increased scrutiny from Regulatory authorities, which may require more rigorous and frequent inspections and audits.
- Product Recalls and Loss of Market Access: Non-compliance with quality and safety regulations can lead to product recalls, which are costly and can further damage a company's reputation. Non-compliance can result in, limiting the company's market access and growth opportunities.
Compliance challenges in the pharmaceutical sector can be complicated and can have long-term effects. To address these issues, pharmaceutical businesses must emphasize on staying compliant by collaborating with expert Global Regulatory services consulting partners like Freyr and building strong quality systems, and data management standards. Freyr can help prevent and mitigate the consequences of non-compliance by offering comprehensive solutions that cover every stage of a product's Regulatory journey.
How can Freyr support you throughout Product Development and Commercialisation?
From early-stage development and at every point through commercialization, Freyr partners with their clients to tackle complex Regulatory challenges. We help ensure that you comply with all the necessary regulations throughout a product’s development and its lifecycle. By consulting with our team of experts, you can benefit from our expertise in preparing documentation that meets the requirements of Health Authorities across the globe, which can expedite the development and availability of medicines with Regulatory strategies tailored to meet your needs.
Our expertise in dossier development, providing pre-application advice and observing Good Submission Practices (GSubP), can help ensure smooth progress through the submission phases in multiple geographies.
Additionally, we can assist in identifying potential Regulatory challenges early in the product development process, advise on post-marketing strategies, and help navigate international regulations and harmonization initiatives.
We can contribute significantly to the strategic planning and execution of your Regulatory activities, increasing the likelihood of successful product registration and market launches.
Our Global Regulatory Services and Solutions
With over 12+ years of experience in Regulatory Affairs, our team of 2300+ in-house Regulatory consultants can propose Regulatory strategies tailored to address your unique requirements at all stages of a product’s lifecycle. These include:
Product and Market Authorizations of Medicinal Products
Product and Market Authorizations of Medicinal Products
- IND, CTA, NDA, BLA, ANDA, IMPD, MAA (CP/DCP/NRP/NP), and NDS, application submissions
- Generic application submissions
- Dossiers for emerging markets, and ACTD (Active Controlled Trials) dossier preparation
- Legal and Local representation to ensure seamless navigation worldwide
Post Drug Approval Services
Post Drug Approval Services
- Change Control assessment and submission strategy
- Preparation and review of post-approval submission packages
- MAH transfers, Site Transfers, Complex Variations
- Grouping and Work Sharing of Variations
- Drug license renewal applications/Renew license application
- Tracking, preparation, and submission of Annual Reports and Re-registration dossiers.
HA Queries and Response Management
HA Queries and Response Management
- Support in the assessment of deficiencies and queries received
- Evaluation of registered dossiers
- Preparation of action plans to address any identified gaps
- Development of a comprehensive Regulatory response submission strategy
- Preparation of response packages to ensure that all queries are addressed
Active Pharmaceutical Ingredient Submissions
Active Pharmaceutical Ingredient Submissions
- Preparation of DMFs (Drug Master Files), CEPs (Certificates of Suitability), MFs (Manufacturing Authorizations), and gap analysis
- Prepare API Master Files for RoW Countries
- Expert Regulatory advice and strategic guidance for API development.
- Regulatory guidance on starting materials
- Preparing reports, renewals, amendments, and variations for product lifecycle compliance.
Health Authority Interactions
Health Authority Interactions
- Preparation of Briefing Books, IBs, and Pre-IND/CTA/NDA meeting packages
- Health Authority meeting participation and question guidance.
- Guidance on the selection of meeting types
- Correspondence with Health Authorities
- Pre-submission support (including support for Scientific Advice Meetings) and managing follow-up queries.
Regulatory Assessment / Gap Analysis Services
Regulatory Assessment / Gap Analysis Services
- Initial Submissions
- Registered Dossier Extension
- Legacy Product Relaunch
- Remediation of Legacy Dossiers
- Lifecycle Management
- Electronic Conversion
License Renewals/ARS
License Renewals/ARS
- Tracking of renewal application/ARs due date
- Send the renewal initiation/AR documents request to the manufacturer
- Regulatory Assessment of supporting documents
- Request for additional documents/justification
- Finalization and Preparation of Renewal Dossier/AR
Regulatory Strategic Consultation
Regulatory Strategic Consultation
Our comprehensive services encompass:
- Regulatory road maps/Intelligence Reports
- Regulatory Strategic guidance on the Drug development phase
- Regulatory guidance on day-to-day manufacturing topics
- Selection of Regulatory Submission Strategy/Procedure
- Due diligence on existing dossiers for market extensions
- Strategies on Core Dossier preparation and reusage
Why choose Freyr as your Global Regulatory Partner?
Medical enterprises frequently encounter complex changes in market dynamics and Regulatory requirements. Keeping up with ever-changing legislation and the distinctive characteristic of each market requires ongoing monitoring.
Freyr has 12+ years of experience with business growth and Regulatory affairs in the Regulatory market. We provide comprehensive Regulatory Affairs services across the spectrum of product development, initial registration, and commercialization.
What makes us different?
Strategic Regulatory Partnership
- More than 80% of our customers are engaged in Strategic Multi-Year Regulatory Partnerships for long-term guaranteed cost and benefit value gain.
- Our growth is based on this core strategy and is heavily invested in fulfilling continuous value-driven partnerships with customers.
One-Stop Regulatory Shop
- We provide multi-product (Pharma, Biologics, Medical Devices, consumer), end-to-end Regulatory strategy, and operational services for 120 + global markets to meet diverse customer needs.
- Our Multi-service Regulatory approach has enabled customers to gain significant tangible benefits.
Optimized Cost Benefit
- We can balance a multi-country delivery approach between strategy-focused local country services, and routine operational services performed from centralized low-cost country locations. This has resulted in cases of Freyr customers achieving 25-60% cost reductions with a commitment to quality and service level expectations.
Quality Benchmarks and Accelerators
- We have developed a number of industry benchmark artefacts for various Regulatory services based on our combined historical customer project experiences.
- These artefacts (process flows, checklists, deliverable SLAs) are quality focused and enable accelerated critical project success.
Global Regulatory Intelligence Framework
- We have invested in developing and maintaining a comprehensive Global Regulatory Intelligence Information Framework that comprises up-to-date global regulations, and HA standings in multiple Regulatory topics.
- This RI Framework is integrated in customer delivery projects for increased market specific critical success.
Regulatory Competency
- Our Strong Global Brand Recognition as a specialized Regulatory services provider that attracts high-performing talent from the industry.
- Our Resources are continuously trained on the changing global Regulatory landscape to keep their knowledge aligned with current trends and developments.
ISO Certified Regulatory Practices
- We are possibly the only Regulatory-focused service provider worldwide that is both ISO 9001 & ISO 27001 Certified to meet Global Health Authority Requirements in the delivery of Regulatory Projects.
- Proven Customer confidence in data security and compliance needs.
Continuous Improvement Initiatives
- More than 60% of customer programs delivered at Freyr are subject to year-on-year continuous improvement initiatives to provide tangible cost and efficiency benefits.
- We are committed to these initiatives in achieving continuous customer confidence and building strong long-term partnerships.
Global Presence
Frequently Asked Questions
Regulatory Affairs (RA) in the pharmaceutical industry involves ensuring the quality, safety, and efficacy of medicines throughout their lifecycle. RA professionals navigate complex global health authority requirements, maintaining compliance from drug discovery to commercialization. They act as a communication link between pharmaceutical companies and Regulatory authorities worldwide.
The primary purpose of regulation in the pharmaceutical industry is to safeguard public health by ensuring that new drugs are safe and effective before reaching the market. Regulatory agencies enforce rigorous standards for testing and evaluation, minimizing potential health risks. This Regulatory oversight provides confidence in the medical treatments available to the public.
Regulatory Affairs professionals ensure that pharmaceutical products comply with Regulatory standards throughout their lifecycle. They are involved in clinical trial design, marketing authorization, and post-approval management, ensuring ongoing compliance and facilitating necessary product changes. Their expertise helps companies bring safe and effective products to market efficiently.
Lifecycle management in pharmaceuticals involves maintaining the viability of a product from development through post-approval. It includes strategies for clinical development, marketing authorization, and ongoing compliance with Regulatory standards. Effective lifecycle management ensures the product remains safe and effective throughout its market presence.
Pharmaceutical regulation has evolved significantly, from medieval drug lists to modern international harmonization efforts. Key milestones include the US Pure Food and Drugs Act of 1906 and the formation of the International Conference on Harmonization (ICH) in 1990. These developments have strengthened global standards for drug safety and efficacy.
Non-compliance with Regulatory standards can lead to significant consequences, including fines, litigation, and product withdrawals. It can damage a company's reputation and result in increased scrutiny from Regulatory authorities. Ensuring compliance is essential to avoid these risks and maintain market access.
Freyr offers comprehensive Regulatory solutions, supporting clients from early-stage development through commercialization. Their services include preparing documentation for health authorities, identifying Regulatory challenges, and advising on post-marketing strategies. Freyr's expertise helps expedite product development and market availability.
Global Regulatory harmonization aims to streamline drug development and registration processes across different countries. It minimizes animal testing and ensures public health by aligning Regulatory requirements internationally. This harmonization facilitates the efficient introduction of new treatments to global markets.
Regulatory agencies such as the FDA in the United States and the EMA in the European Union enforce standards to ensure drug safety and efficacy. They oversee comprehensive testing and evaluation processes before drugs can be marketed. These agencies balance the need for new treatments with minimizing potential health risks.
Freyr's Global Regulatory intelligence framework provides up-to-date information on global regulations and Health Authority standings. This framework is integrated into customer/ client projects to enhance market-specific success. It supports strategic planning and Regulatory compliance across multiple geographies.