A company should outsource its regulatory submissions when internal resources, expertise, or bandwidth cannot reliably support the submission workload or the complexity of the regulatory pathway involved. This applies to companies at any stage, from early-stage startups preparing their first dossier to established organisations managing multiple concurrent applications across different markets. The questions below unpack the most important considerations in deciding when and how to outsource.
What are the most common signs a company needs regulatory outsourcing?
The clearest signs that a company needs regulatory outsourcing are a lack of in-house expertise for a specific submission type, mounting backlogs, upcoming regulatory deadlines that the internal team cannot meet, and the cost of hiring full-time staff outweighing the volume of work. Any one of these signals is worth taking seriously.
Beyond capacity, expertise gaps are often the most consequential trigger. Regulatory requirements vary significantly by product type, market, and submission category. A team experienced in small molecule applications may not have the depth needed for a biologics dossier, a combination product, or a Class III medical device. Attempting to bridge that gap internally takes time that most development timelines do not allow.
Other common signals include:
- Regulatory staff spending the majority of their time on administrative tasks rather than strategy
- A product entering a new market where local regulatory knowledge is limited
- A change in the regulatory landscape requiring updated compliance work, such as new EU requirements
- Business growth outpacing the regulatory function’s ability to scale
- A one-off or short-term project that does not justify a permanent hire
If several of these apply at once, outsourcing is not just a practical option but often the most responsible one. To understand how a specialist consultancy can address these challenges, take a look at our regulatory affairs services and the full range of support we offer.
Is outsourcing regulatory submissions cost-effective?
Outsourcing regulatory submissions is cost-effective in most scenarios when compared to the full cost of recruiting, onboarding, and retaining specialist regulatory staff. The key advantage is that you pay for expertise when you need it, without carrying the overhead of a permanent headcount during quieter periods.
The cost comparison becomes even more favourable when the submission in question requires specialist knowledge that sits outside the core competency of your existing team. Hiring a full-time expert for a single submission type, such as an ATMP or an in vitro diagnostic, rarely makes financial sense. A consultancy already has that expertise on hand.
There is also a risk-cost dimension to consider. Delays caused by regulatory errors or incomplete dossiers can be expensive, both in direct costs and in lost time to market. Working with experienced regulatory professionals reduces that risk, which carries its own financial value.
What types of regulatory submissions are best suited to outsourcing?
Regulatory submissions that are best suited to outsourcing are those requiring specialised expertise not readily available in-house, those with tight timelines, and those that are non-recurring. Complex submissions such as biologics, ATMPs, combination products, and Class III medical devices are particularly well-matched to outsourced support.
That said, outsourcing works well across a broad range of submission types, including:
- Marketing authorisation applications (MAAs) and variations
- Clinical trial applications (CTAs)
- Orphan designation and scientific advice requests
- Medical device technical documentation and conformity assessments
- Post-approval changes and lifecycle management submissions
- Publishing and dossier formatting for eCTD submissions
Even companies with strong internal regulatory teams regularly outsource specific components of a submission, such as CMC documentation, gap analyses, or regulatory strategy for a new market. Partial outsourcing is just as valid as full outsourcing, and it allows internal teams to stay focused on their core responsibilities.
How does outsourcing affect control over the regulatory process?
Outsourcing regulatory submissions does not mean losing control over the regulatory process. When structured correctly, an outsourced arrangement gives a company access to greater expertise while the internal team retains strategic oversight, final approval authority, and full visibility into submission progress.
The key is how the relationship is set up from the start. A well-run consultancy will work as an extension of your team, not as a black box. This means clear communication channels, defined deliverables, regular progress updates, and a single point of contact who understands your product and your business goals.
Control concerns typically arise when expectations are not clearly defined at the outset. To maintain meaningful oversight, companies should:
- Agree on a project plan with milestones and review points
- Ensure the consultancy uses or aligns with your internal quality management system
- Retain final sign-off on all submissions before they are filed
- Establish a named contact on both sides responsible for the relationship
With these structures in place, outsourcing typically enhances rather than reduces the quality and reliability of the regulatory process.
What should a company look for in a regulatory affairs consultancy?
A company should look for a regulatory affairs consultancy with demonstrable expertise in the relevant product type and market, a track record of completed submissions, clear communication practices, and a genuine understanding of both the scientific and business dimensions of the regulatory process. Learning more about our background and approach can help you assess whether a consultancy is the right fit for your organisation.
Relevant experience is the most important criterion. Regulatory affairs is a broad field, and a consultancy that excels in medical devices may not have the depth needed for a complex biologics application. Ask specifically about experience with your product category, the markets you are targeting, and the submission types you anticipate needing.
Beyond expertise, practical factors matter:
- Team structure: Lean teams with short reporting lines tend to communicate more efficiently than large organisations with multiple layers of management
- Quality systems: Look for consultancies that operate under a documented quality management system and adhere to GxP and relevant ISO standards
- Flexibility: The consultancy should be able to scale support up or down depending on your project pipeline
- Transparency: Pricing, timelines, and scope should be clearly defined before work begins
- Network: For complex or niche submissions, access to a broader expert network can make a significant difference
A good consultancy functions as a long-term partner, not just a vendor. Look for a team that asks questions about your business goals, not just your regulatory requirements.
How Starodub helps with regulatory submissions
We support biopharmaceutical and medical device companies at every stage of the regulatory submission process, from strategy and gap analysis through to dossier preparation, filing, and post-approval lifecycle management. Whether you need full submission support or targeted expertise for a specific component, our team adapts to your needs.
Here is what working with us looks like in practice:
- Expert support across small molecules, biologics, ATMPs, vaccines, and medical devices from Class I through Class III
- Regulatory strategy and pathway guidance tailored to EU requirements and evolving frameworks
- CMC expertise underpinned by our founder’s background in regulatory CMC from leading pharmaceutical companies
- A single point of contact backed by a team of specialists and a broader network of subject matter experts
- A quality management system aligned with GxP and ISO 9001/13485 standards, giving you confidence in the quality of every deliverable
- Over 400 completed projects across more than 300 clients, spanning a wide range of product types and markets
If you are weighing up whether to outsource your regulatory submissions or looking for a consultancy that can genuinely act as an extension of your team, we would be glad to talk through your situation. Get in touch with Starodub to discuss your regulatory needs and find out how we can support your path to market.
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This content was generated with the help of AI and it may contain mistakes
