Worldwide Regulatory Solutions

At Worldwide Regulatory Solutions we understand the needs of our customers and the importance of sound regulatory strategies within a complex and ever-changing environment.

With experience globally, a network of international expertise and a customer focused approach, WWRS is committed to delivering superior quality regulatory services that enable our clients to expedite product development programs, product approvals, divestitures, and marketing.

With extensive experience in regulatory affairs and product development, we understand the financial burden and time pressures related to product development and work in partnership with you to maximize opportunities and meet key milestones on time and on budget.

WWRS has the experience and knowledge to support your needs throughout the entire product lifecycle, from early consultations defining the regulatory development strategy, to clinical trial and marketing authorization submissions, through to post-licensing support. Our service portfolio ranges from NCEs, to biological/biotechnological products and generics.

In addition, our in-house expertise in drug-device combination products and medical devices ensure that we can offer a range of strategic and operational services, including clinical investigation submissions,CE-marking expertise, and pediatric investigation plan services

We are flexible to the individual requirements of our clients and tailor our services to meet our clients’ short- and long-term needs, whether they are small companies driving their drug portfolio through early development and require assistance with clinical trial submissions or Regulatory Authority Consultation, or medium to large sized companies submitting an MAA and/or NDA, or requiring support with post-licensing activities.

In addition to being regulatory professionals with broad therapeutic expertise and experience with the Centralised, Decentralised and Mutual Recognition procedures as well as NDAs, and PIPS, the WWRS regulatory team also includes experts with industrial experience within the specialist disciplines of quality, non-clinical and clinical, who have a sound knowledge and understanding of the philosophy and requirements of the SFDA, EMEA, MHRA, and other international regulatory authorities and are able to offer strategic input into the development of your product.

We pride ourselves in providing a service of the highest quality delivered within pre-agreed timeframes. Our focus is always the needs and best interests of our client.
WWRS in combination with its global strategic alliances has a team of experienced professionals operating with global capabilities to provide a full cadre of strategic consulting and regulatory services to clients worldwide.

From Concept to Commercialization. We are your “Regulatory Partner for Life”