For organizations operating in pharmaceuticals, biotech, medical devices, and consumer healthcare industries, regulatory compliance is important for getting their products approved and marketed. However, it may take quite some effort from the organizationās side to maintain a fully-fledged in-house team of regulatory affairs professionals.
Thatās when regulatory affairs outsourcing can help. The organization can team up with a trusted regulatory affairs outsourcing firm that will help them get all of the necessary expertize in submissions, registrations, and regulatory activities without developing everything in-house.
But is regulatory affairs outsourcing worth the money? Which services can be outsourced? How to choose the right outsourcing firm?
What Is Regulatory Affairs Outsourcing?
Regulatory affairs outsourcing involves engaging an external regulatory consultancy firm to handle the companyās regulatory affairs either partially or completely.
Based on the company’s requirements, regulatory affairs outsourcing might consist of regulatory strategy, regulatory intelligence, dossier compilation, submission publication, product registration, labeling, art work check, health authority liaison, and post approval lifecycle management.
Outsourcing helps a firm enter new markets or deal with multiple products because it gives access to regulatory experts experienced in dealing with many health authorities.
Why Are Companies Outsourcing Regulatory Affairs?
The regulations vary in complexity, are constantly being revised and are unique for each market. A firm that is planning to register its products in such markets as EU, USA, GCC, ASEAN and others will require country-specific expertise in regulation.
Having this kind of expertise in house is not always feasible for many firms, especially for start-ups, emerging pharmaceuticals, biotechnology and internationalizing firms.
Regulatory outsourcing gives firms an opportunity to employ specialized skills only when needed and creates a business model that can support project-based and sustained regulatory processes.
Key Benefits of Regulatory Affairs Outsourcing
1. Access to Regulatory Expertise
One of the biggest advantage of outsourcing regulatory function is access to experience. An experienced provider would possess regulatory experience that would cover different types of products, submissions, health authorities, and markets.
Such experience would be particularly useful when the in-house team has little experience in a specific market.
2. Reduce Regulatory Affairs Costs
Cost reduction is also another important factor which leads to regulatory outsourcing.
Having a regulatory team internally would mean salary costs, recruitment cost, training cost, software cost, professional development costs etc. Regulatory outsourcing may allow to change some of these costs into variable cost of services.
But again, there will be variation in the cost of regulatory affairs outsourcing depending on the nature of the job, complexity of the products, number of markets, submissions and other factors. Therefore, companies must look at the overall cost of outsourcing versus that of internal capability.
3. Scale Regulatory Support as Needed
The regulatory workload is likely to vary considerably depending on the stages involved in product development, registration, and commercialization.
While more staff may be needed during important submissions, less would be required when dealing with normal maintenance of a regulatory system.
This allows for flexibility in staffing according to the workload, which is advantageous for startups that are growing rapidly.
4. Support Faster Market Entry
Regulatory delays could affect the launch schedule of a product. Regulatory experts will be in a position to assist in identifying documentation requirements, conducting dossier gap assessment, and handling other regulatory functions effectively.
For instance, the regulatory services provided by Pharma Wizard include strategies, registration, submission assistance, labeling, regulatory information management, and post-approval activities.
It is important to note that outsourcing does not guarantee approval of a drug and an approval time frame, but having the appropriate partner would help prevent unnecessary delays in the process.
What Regulatory Affairs Services Can Be Outsourced?
The extent of the regulatory affairs outsourcing services will vary depending on what the company wants. Some of the usual services include:
- Strategic and intelligence regulatory affairs
- Applications for product registration and marketing authorization
- Regulatory dossiers preparation and review
- Regulatory medical and technical writing
- Regulatory publishing and submission management
- Communication with health authorities
- Labeling and artwork review
- Variation and renewal management
- Post approval lifecycle management
- Regulatory information management
- Regional regulatory affairs services
If a company is international, the outsourcing service can help it grow in other countries. According to Pharma Wizard, its global outsourcing model helps life science organizations enter and expand their operations internationally.
What Are the Factors That Influence the Cost of Outsourcing Regulatory Affairs?
The cost of outsourcing regulatory affairs differs with regard to the needs of the organization and the extent of the projects that the organization wants done. These include the type of product, regulatory path, intended markets, number of countries, and complexity of submission, documentation needs, project timeline, and expertise needed.
An organization may be facing different costs depending on whether it requires assistance with just one submission or a continued regulatory process in several markets. Organizations should ensure they know the scope of the services provided by the regulatory affairs outsourcing company before hiring one.
Factors to Consider Prior to Selecting a Regulatory Outsourcing Firm
Selecting a firm that specializes in regulatory affairs should not just boil down to cost comparison. Find a firm that has experience in your category of products, targeted markets, regulatory approaches, and submissions.
You should also assess issues like communication, quality system, data security, project management, expected turnaround time, and reporting.
In international engagements, it is very helpful to have the local regulation expertise. Pharma Wizard has experience in the pharmaceutical industry, the medical devices market, consumer health care sector, among others.
Outsourcing of Regulatory Affairs, is it the Right Choice for You?
Regulatory outsourcing can work well for companies requiring specialist knowledge, cost savings, market entry or more regulatory resource without growing their headcount.
The way to go here may not be the total outsourcing. Companies tend to opt for a hybrid regulatory approach where some functions remain in-house while others are outsourced. The choice will depend on your product portfolio, regulatory footprint, resources and budget.
Final Considerations for Regulatory Affairs Outsourcing
Regulatory affairs outsourcing is now a common strategic choice for life science firms that seek to gain expertise, reduce costs, scale operations, and gain global market access.
The important point here is that you choose an outsourcing company that can meet your regulatory needs, rather than just provide inexpensive regulatory services. An effective outsourcing company should be able to work together with your existing personnel, maintain quality and compliance, communicate well, and be flexible enough to adjust to your evolving regulatory needs.
For companies considering regulatory affairs outsourcing, the important question is not only how much does it cost, but what do you get for your money?
Frequently Asked Questions About Regulatory Affairs Outsourcing
1. What is regulatory affairs outsourcing?
Regulatory affairs outsourcing is an approach wherein a company outsources its regulatory affairs management to an external agency or consulting firm that handles all regulatory work including the registration of products and dossier development among others.
2. What are the key advantages of regulatory affairs outsourcing?
Some of the most important benefits are access to specialized knowledge, lower overhead costs, flexible staffing, and support in foreign markets, improved regulatory processes, and scalable resources.
3. How costly is the outsourced regulation?
The cost will depend on the type of product, regulatory requirement, market targeted, and duration of project, and requirements for submission. A tailored quotation based on the scope of the project would be more helpful than an average cost.
4. How do I choose a regulatory affairs outsourcing company?
Think about the service provider’s history with regulation, geography, product expertise, quality control, communication skills, project management, scalability, and performance history. The perfect service partner will not only be familiar with your present regulatory requirements but your future market growth plans as well.
