Consulting Regulatory Affairs Services for Pharmaceutical companies
25 November 2021
The regulatory affairs process is a critical component of the safe development, registration and commercialization of pharmaceuticals. There are numerous factors to consider when developing a strategy for regulatory affairs, including information management, scientific writing, clinical trial design and conduct, regulatory submissions, pharmacovigilance activities as well as interactions with regulators from multiple jurisdictions. This post will explore what you need to know about regulatory consulting services in this rapidly changing environment.
In particular we will focus on how an experience team can help you with your outsourcing regulatory activities related to these areas. We hope that this article will provide an insight into how outsourcing regulatory affairs can leverage better business outcomes for all clients; including biotech’s, small and mid-sized pharma, large international organizations, and medical device companies.
- What is regulatory affairs and why is it important?
The regulatory affairs function encompasses all activities that demonstrate compliance with regulatory requirements during product development, registration and commercialization of biopharmaceuticals or medical devices.
The regulation of human medical products (biopharmaceuticals, medical devices) is crucial because it ensures both the safety and efficacy to patients who receive them. It also helps assure that, amongst other things, manufacturing processes are well controlled and documented (quality assurance), compliance with laws and regulations is demonstrated, the marketing of products is compliant locally, and consumer rights are protected.
This includes convening with other functions on potential regulatory issues, consulting (clinical affairs, medical affairs, marketing communications,.) with third parties including vendors, consultants and other companies on relevant regulations, designing strategies to ensure appropriate documentation is generated during clinical trials to support product approvals and with identifying areas where operational efficiencies can be gained in the regulatory submissions process.
There are four main areas of regulatory compliance:
- Industry guidelines: These are the most frequently encountered by companies, and they generally exist to help ensure that products remain as safe and effective as possible.
- Clinical trial regulations: Many countries have specific laws and regulations to support the conduct of clinical trials, which must be followed by anyone conducting a clinical investigation involving human subjects.
- Regulatory requirements: In order for a product to be approved/launched in a country, the sponsor company must provide evidence that it meets all applicable regulatory requirements.
- Pharmacovigilance: Some countries require a mandatory pharmacovigilance level of safety monitoring for all marketed medicines including biopharmaceuticals.
- The importance of Regulatory Strategy
Ultimately, there is no substitute for good planning.
A regulatory strategy must be developed early in a pharmaceutical biotech company's life cycle. This will enable the client and the team to better understand what needs to be achieved, how long the process will take, and to identify the adapted pathways to get to obtain the smoothest and quickest regulatory approval.
The end goal of developing an effective Regulatory Strategy is to ensure that appropriate resources are available to achieve the desired regulatory outcomes with a realistic timetable and lower risk.
This means that early in a company's life cycle, it is important to identify what resources or capabilities will be required to achieve regulatory objectives and analyze the type of expertise within the company and how it can be leveraged most efficiently.
If you are an emerging biotech company, you should consider what consultants can do to support your efforts that will free up your company resources to focus on other activities such as clinical development.
You may also be able to negotiate lower fees based on future business opportunities.
Our experienced team of regulatory experts can help you determine your regulatory strategy and identify your goals and requirements to meet those goals; whether that be filing in specific jurisdiction (for instance EMA, FDA, international & local market), completing registration dossiers quickly and with a high level of quality, ensure regulatory compliance in a specific market or general global regulatory affairs activities.
During this process we help pharmaceutical companies:
- Identify key activities and regulatory needs
- Determine the timeline for completion
- Identify the resources required to complete those activities.
In many cases your consulting team can help recruit or manage resources including scientists, managers and other consulting partners to complete complex projects on time and within budget.
- Regulatory affairs outsourcing is on the rise
Outsourcing of regulatory affairs activities is on the rise as companies recognize that there are more efficient ways to manage their clinical trial programs and gain efficiencies in their regulatory submissions process. This can be achieved through either full outsourcing, partial out-sourcing or near-shoring options.
Pharmaceutical companies are increasingly outsourcing the management of their product registration packages to regulatory consultants or specialist firms that have extensive knowledge in managing international product registrations. For example, clinical operations outsourcing has become common for biopharmaceutical companies, especially continuing to focus efforts on late-stage development during an economic downturn. However, for companies that find it difficult to outsource clinical trials or do not wish to cede control of the clinical trial process, there are other ways to leverage outsourcing opportunities.
Companies can also look for regulatory experts who can provide consulting services in areas such as international medical writing, launch regulatory compliance, lifecycle management, pharmacovigilance, which can help support the generation of submissions and drug launches in emerging markets, or in more complex global regions such as Europe.
This is an area where many companies face challenges due to lack of resources, regulatory science or knowledge, and outsourcing options are available through CROs that focus on providing very specific services.
- What are the benefits of regulatory consulting services?
There are many benefits to use outsourced regulatory and quality solutions during your drug development, registration phase and commercialization, life cycle management journey.
For instance, our Regulatory affairs teams have worked on many diverse projects across the biopharmaceuticals industry, including regulatory consulting activities related to drug development, marketing authorizations, launch regulatory compliance to name a few. We understand the importance of being able to clearly identify requirements early in the process in order to mitigate risks and achieve a successful outcome.
As well as helping you identify your requirements, regulatory affairs consulting services can help you file with the relevant regulatory agencies, manage submissions throughout product lifecycle and ensure compliance with all regulations.
Below are some of the key benefits to working with regulatory affairs consulting firms:
- Leverage your internal resources and focus for instance, on clinical trials
- Ensure regulatory compliance and optimize time to obtaining approval in target markets
- Keep control of budget & operations
- Hiring a consultancy that is independent of the clinical trial supply chain will provide you with unbiased advice throughout the process.
- Regulatory Affairs consulting services – Key considerations
1. Quality and timelines: Ensuring that regulatory consultants deliver high quality results within your timeline is critical. Without this, you could find your consulting engagement straddling multiple regulatory deadlines and delaying your commercialization process.
2. Regulatory advisory services providers: Working with an outsourced regulatory affairs team that has a proven track record of success in the biopharmaceutical industry can help you get to market faster and ensure compliance at all times.
3. Expertise: Look for regulatory consultancy that offer expertise across different market segments such as oncology, cardiovascular and other therapeutic areas.
- Regulatory Affairs consulting services – Key deliverables:
Our team can help develop a regulatory strategy that will meet your needs and timelines; we can also manage the process from initiation through to completion. There are several other key benefits:
- We build relationships with regulators around key upcoming milestones, translating them into effective strategies. This helps you navigate the regulatory process with confidence and ensure that submissions are compliant at every step.
- We take project management seriously, assigning one PM to oversee the full process, ensuring that timelines are met, and key deliverables are completed on time.
- Our Regulatory affairs consulting services team will help you identify your needs, whether they are related to quality, timelines, resources etc. and work with you to develop a tailored plan and timeline for completion.
BlueReg is a leading consultancy offering regulatory support to life sciences companies developing, registering, and commercializing their innovative treatments in Europe and beyond.
If you want to know more about our regulatory services and how we are helping our clients,