Outsourcing is becoming increasingly common in pharmaceutical, medical device, and biotechnology, industries, especially in regulatory affairs and pharmacovigilance domains. Large and small companies alike are now turning to outsourcing vendors to manage regulatory affairs and maintain regulatory compliance. Regulatory outsourcing is becoming a common norm. Hence, an increasing number of companies are seeking the expertise of regulatory affairs professionals to ensure regulatory compliance. In this blog, we have provided some tips for outsourcing regulatory affairs team. Moreover, we have discussed the responsibilities of regulatory affairs partners. Additionally, we have highlighted the key benefits of regulatory outsourcing.
What is regulatory affairs?
Regulatory affairs is a multidisciplinary field overseeing the compliance of medical devices, pharmaceuticals, and food products with regulatory guidelines and global quality standards. Regulatory affairs professionals are responsible for ensuring the manufacturer’s compliance with regulations and legal requirements during the entire product lifecycle. They ensure the research and development, manufacturing, marketing, and post-market surveillance are per set regulatory guidelines. They work as a liaison between companies and regulatory agencies, thereby ensuring compliance and facilitating fast product approval. These professionals focus on facilitating the commercialization of safe and effective medical devices, pharmaceuticals, and food products.
5 key roles of the regulatory affairs team:
- Submission of necessary regulatory documents: The regulatory affairs team is responsible for preparing and submitting the necessary documents to regulatory agencies for approval for marketing.
- Overseeing the entire product lifecycle: The team oversees the entire product lifecycle from research and development and clinical trials to manufacturing, marketing, and post-market surveillance for regulatory compliance.
- Compliance with all applicable regulatory guidelines: The regulatory affairs team is responsible for ensuring the product complies with all applicable regulatory guidelines.
- Regulatory guidance: Compliance with regulatory guidelines is a mandatory requirement for medical device, pharmaceutical, and food industry. Regulatory affairs professionals provide advice to companies on how to comply with regulatory guidelines and industry standards. Additionally, they help prepare the documents, file applications, and update the company on the latest changes in guidelines.
- Act as a liaison: The regulatory affairs team acts as a liaison between the company and regulatory authorities.
Why should you outsource your regulatory affairs team? 5 Key benefits
Regulatory outsourcing is the process of delegating responsibility of regulatory affairs to an external team. Benefits of regulatory outsourcing mostly outweigh the costs. We have highlighted certain key benefits.
- Regulatory expertise: Knowledge of applicable regulatory guidelines is required to ensure regulatory compliance. Furthermore, regulatory guidelines are constantly evolving. By outsourcing your regulatory affairs team, you can leverage the expertise of experienced regulatory professionals.
- Allocation of time and resource to core business: By outsourcing regulatory affairs, you can focus on research and development. The outsourced team can handle documentation and secure regulatory approvals as well as deal with all the hassle.
- Cost efficiency: Outsourcing regulatory affairs requires you to pay only for the services you need. Thus, you can avoid the costs associated with maintaining an in-house team.
- Quick regulatory approvals: Experienced regulatory professionals will streamline and expedite the regulatory processes, ensuring quick approval of products.
- Easily expand to new markets: If you are planning to expand to new markets, outsourced experts can help you easily navigate local regulatory frameworks. Hence, you will be able to easily launch your products in new markets without regulatory hassles.
Hence, a large number of companies are turning to regulatory affairs partners to manage all regulatory needs. Regulatory outsourcing helps bring products to the market faster with fewer regulatory hurdles.
10 points to keep in mind when outsourcing regulatory affairs
We have discussed certain parameters you should keep in mind while selecting your outsourced regulatory affairs team.
- Industry-specific experts: Hire professionals with experience in your specific sector be it pharmaceuticals, food, biotechnology, or medical devices. It is vital for the regulatory affairs team to have industry specific knowledge.
- Proper certifications and credentials: Check whether the team has industry-recognized credentials and regulatory affairs certification (RAC) or other applicable certifications.
- In-depth regulatory knowledge: Check whether the team has extensive knowledge of the global and regional regulations and industry guidelines.
- Seek client reference: Seek recommendation from past and current clients regarding the quality of work delivered. This will also help you understand whether the team’s goal and expertise align with your expectations.
- Flexibility: The regulatory partners should be flexible and willing to adapt to changing project needs.
- Technological capabilities: The regulatory partners should be proficient in handling regulatory software and data management tools to streamline and expedite application processes. Additionally, check whether they have advanced regulatory software for efficient documentation and compliance tracking.
- Open communication: Strong communication skills and quick response to queries are essential for seamless coordination between the outsourced regulatory affairs partner and internal team.
- Data security and confidentiality: Ensure the regulatory affairs team has sufficient measures in place to protect sensitive regulatory information and maintain confidentiality.
- Cost efficiency: Review their pricing models. Furthermore, check whether you are getting value for money without compromise on quality.
- Proven track record: Review the team’s past projects. Check their success rate and time required for obtaining approvals and maintaining compliance.
Questions to ask when choosing a regulatory outsourcing partner
Companies need to maintain a long-term relationship and successful partnership with their potential regulatory outsourcing partner. Hence, it is vital to wisely choose the potential regulatory outsourcing partner. We have listed some questions to ask before narrowing down on your prospective outsourcing team.
- Does the regulatory affairs team have a track record of service commitment?
- Does the regulatory outsourcing team have the requisite experience and expertise?
- Do they have the necessary global reach?
- How good are the service level agreements they offer?
- Do they have a good relationship management protocol in place, which is critical for business?
- Are they prompt in responding to queries from the outset?
- How will the partnership be managed? Is the approach both personal and professional?
- How good is the contact(s)?
- How do they propose to report progress?
- What is the reputation of the service provider within its own industry?
- Do they track customer satisfaction levels?
Pharmadocx Consultants: Your trusted regulatory affairs partner
With over 27 years of experience and more than 600 clients, the Pharmadocx Consultants team has extensive industry knowledge and regulatory expertise. We are well placed to offer regulatory support and service to our clients. As India’s leading regulatory consultant, we will help you navigate through regulatory nuances, thereby assisting you in achieving regulatory and operational excellence.
Our service ranges from license application filling, document preparation to mock audit service and acting as a liaison between clients and regulatory authorities. Our support does not end with successful license grant. We provide continued post license approval support. Our team will help you maintain compliance with constantly evolving guidelines and we will help you with your license renewal needs. Additionally, we will help design manufacturing facilities per regulatory guidelines. Our detailed project report is a comprehensive tool for launching a successful business. Furthermore, we provide authorised agent service to foreign manufacturers who want to enter the Indian market. To hire us as your trusted outsourced regulatory affairs team, drop an email at [email protected] or call/Whatsapp on 9996859227. Our team will guide you in every step of your regulatory journey helping you easily launch and grow your business venture.
