The strategy planning services involve comprehensive planning of the approach which is to be taken and executed to get best results. CliniExperts aims to empower our clients with the knowledge and understanding of the regulatory environment and processes. This is vital to our clients to understand the regulatory environment and be ahead of the competition. It enables them to make informed decisions regarding their products and the method we are employing to launch their product.
- CliniExperts consists of a highly experienced and reliable team which assists our clients in selecting the appropriate geographical regions for the Registrations of Dossiers in Semi-Regulated [Rest of the world (ROW)] and Regulated markets. Such a selection is based upon the availability of the data to further guide them to strategize filing of dossiers in developed countries. Such a planning results in reducing the timelines for the placement of Products to be exported.
- We also provide tactful and operational directions to our clients for working in compliance with regulatory guidelines so as to expedite the launch of Pharmaceuticals.
- We also cater advisory and management support to our clients to make them aware about current, newly finalized or proposed regulations, guidelines and standards as well as its impact on the registration. Subsequently, we make the recommendations accordingly.
- CliniExperts also provides regulatory input services prior to product lifecycle planning. In regard to this, we assist our clients by sharing the modified product lifecycle planning strategy with respect to the change in the regulatory requirements as per country’s health authorities, requiring regulatory approvals.
- We also monitor the impact of changing regulations on submission strategies. Moreover, we keep our customers updated, on regular basis, about the regulatory changes impacting the Registration status of specific product pipeline of our clients. (In terms of labelling requirements)
Write PSUR (Periodic Safety Update Reports)
PSURs are reports which provide evaluation data of a product’s benefit-risk ratio which includes results of all studies/ trials conducted to evaluate its safety and efficacy. The regulatory authorities use PSURs data to determine the newly identified risks associated with a product. They also evaluate the previous and modified risk benefit ratio of a product using PSUR. This allows them to decide the further investigations that are required for protection of the public from the risks identified.
Marketing authorization holders (MAHs) are responsible to submit PSURs at a defined time and in the required format. CliniExperts is a global leader in regulatory consulting and Periodic Safety Update Report (PSUR) solution for export registration in CIS and other countries. We write and review PSURs as per European Common Technical Document (CTD) guidelines. We also take the responsibility to submit the PSURs to the authorized departments for perusal.
- Worldwide marketing authorization status
- Overview of exposure and safety data
- Actions taken in the reporting interval for safety reasons
- Changes to reference safety information
- Estimated exposure and use patterns
- Summaries of significant findings from clinical trials in the reporting interval
- Findings from non-interventional studies
- Information from other clinical trials and sources
- Non-clinical data
- Discussion and conclusions on PSUR data