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Regulatory Expertise
We know that the regulatory process can be complex and time-consuming. At Bespak, we not only have in-depth experience of navigating regulatory pathways — we work to shape them. We can provide support from regulatory strategy to submission writing, sharing key insights throughout the process to help streamline your regulatory journey and get your drug-device combination product to market.
Our expertise
Our team of regulatory experts is dedicated to supporting customers throughout the process. Beyond experience of the regulatory landscape, many of the team members have an engineering, QC or manufacturing background, ensuring that first-hand understanding of the products strengthens their technical insights.
To ensure we are at the forefront of regulatory standards, we maintain key affiliations. For many years our team have been members of The Organisation for Professionals in Regulatory Affairs (TOPRA). We are members of The Regulatory Affairs Professionals Society (RAPS) with team members becoming RAC certified. For several years, Bespak has been a member of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC -RS), where we are proudly represented on the Board.
Shaping regulations through the green transition
With the pMDI sector in the midst of its transition to low Global Warming Potential (GWP) propellants, the regulatory landscape is also shifting. As regulators develop and refine their guidelines, the industry has an opportunity to help shape the regulatory pathways for low carbon pMDIs.
At Bespak, we are committed to driving this new era of pMDIs, and this includes participating in the regulatory conversation. Our membership of IPAC-RS allows us to contribute to discussions and workshops, amplifying the voices of our customers. As a leader in the green transition, we have an in-depth understanding of - and relationships with - the regulators, which helps us to help our customers.
Our support
We are dedicated to ensuring the success of your innovation — from concept through to commercial supply — and this includes the regulatory process. As part of our end-to-end drug and device development and manufacturing services, we can support you with:
CMC and Device regulatory strategy for new product development
Regulatory strategy for transferring products to the next generation of propellants
CMC dossiers and briefing book preparation
Regulatory intelligence for existing product expansion into new markets
Regulatory maintenance of existing products
Creation, management and maintenance of DMFs, 510(k), technical files
Notified body applications and audits
