Regulatory

Pharmavise offers the following Regulatory services.

Our Regulatory Services

Regulatory Strategy and Gap Analysis

We set you up for regulatory success by managing the entire process from dossier writing to filing applications. To achieve your regulatory and business goals, we tailor comprehensive regulatory affairs strategies for your product, ensure milestones are met, and pave the way for successful submission

Chemistry, Manufacturing and Controls (CMC)

Our Reg CMS regulatory affairs experts possess a robust combination of strategic experience and knowledge to ensure that CMC practices are undertaken in line with the requirements of regulatory bodies, such as the EMA (European Medicines Agency) and FDA (US Food and Drug Administration). Effective regulatory CMC project management is essential in ensuring that the vital drugs and treatments that are being manufactured are safe, effective and of sufficiently high quality for patient use.

FDA Meeting Strategy

FDA meetings play a critical role in any sponsor’s development strategy. They provide sponsors the opportunity to seek out critical agency feedback, identify gaps in required data, and come to agreement on whether the studies that have been conducted are sufficient for FDA review. These meetings also provide sponsors the opportunity to educate the FDA about their product – so reviewers have a basis of background and understanding once the NDA is submitted.

Pre-Approval Audits

Inspections by regulatory authorities are restarting across the world. Companies can help ensure that they are ready for these inspections by utilizing third-party specialists to audit their facilities. Our team of former inspectors from the FDA, the MHRA and other regulatory bodies, along with our experienced industry specialists, are currently working with companies around the globe to prepare them for upcoming inspections.

FDA Submissions Regulatory Due Diligence

When looking to partner with another company through an in-license transaction or collaboration agreement, or when seeking to acquire a product outright from another company, you should undertake due diligence on a number of FDA items before entering into such a transaction.

Non-Clinical Drug Development

Our experts will help to expedite your drug or medical device development program, providing insights and guidance to design the non-clinical program from the start, as well as support and expertise to enhance existing programs. Our nonclinical development experts will work with you to design and implement a cost-effective non-clinical program with a focus on shortening development timelines and ultimately to accelerate your product to market.