Welcome to Inter Regulatory, your regulatory services provider.

The first stage of any regulatory product is that of strategy development. What is meant by strategy is; the approach to which a client seeks to obtain a Market Order or equivalent from FDA, including the legal route and the identification of data required to meet FDA’s threshold.

Determining the appropriate scientific strategy will save substantial cost and time and substantially decrease the risk of FDA deficiencies or Refuse to File.

All clients are encouraged to engage directly with FDA prior to submission of a PMTA or MRTPA. With Inter Regulatory as your Authorised Representative we assume responsibility for the meeting preparation and conduct. From preparation of a scientific briefing document to the circulation of FDAs minutes, Inter Regulatory will navigate the meeting nuances and translate minutes into actionable tasks.

Both PMTA and MRTPA require a substantive dossier to be submitted to FDA for evaluation. Dossiers are complex and require expertise in Regulatory Affairs and a multidisciplinary knowledge and competence of all relevant sciences; toxicology, physiology, chemistry, biochemistry, environmental science and psychology.

Inter Regulatory followed FDA best practice in dossier generation, using the recommended eTTD format which reduces the time and cost of making future amendments and future submissions to FDA.

Substantial data from Human Health Studies (HHS) are required in order to substantiate any PMTA and MRTPA. Inter Regulatory offers a complete service of HHS through a combination of our laboratory in the United Kingdom and through working with a broad network of non-clinical and clinical partners.

Our expertises and capability include the following:

• Product Characteristics and Characterization
• Product Safety Testing (devices)
• Product Stability Studies (devices, e-liquids, HTPs)
• Harmful and Potentially Harmful Constituents (PMTA and MRTPA)
• Human Factors Testing
• Clinical Studies (PK/PD)
• Toxicological Risk Assessments
• Non-clinical studies
• Environmental Impact Assessment
• Population Modelling
• Biomarker of Harm/Exposure Studies

For smaller manufacturers or those who do not have an internal Regulatory Affairs department or for those based outside of the United States, Inter Regulatory adopts the official role of Authorised Representative. The purpose of the Authorised Representative is to manage contact with FDA and to ensure that all communication is promptly responded to in an appropriate manner.

For many, dealing with FDA presents unfamiliar territory with uncertainty as how to appropriately respond to queries or to make requests. With Inter Regulatory as your Authorised Representative we will ensure that your regulatory projects are professionally managed with FDA and that prompt and timely communication of all requests is made.

As with all new regulatory processes, it is highly unlikely that any application will be without question or comments. FDA may raise a ‘Deficiency Letter’ which affords the Agency the opportunity to seek further information or clarification on data which has or has not been presented within an application. It is imperative that Deficiency Letters are responded to in a timely manner to ensure that FDA does not Refuse to File the application.

Deficiencies may require further scientific data to be submitted within the predefined time frame of 90-days meaning that some studies would not be possible. Applicants are encouraged to act immediately upon receipt of a Deficiency Letter. With Inter Regulatory by your side our team will put your interests first and ensure a timely response in a pragmatic manner to reduce the risk of application rejection.

An important tool for PTMA and MRTPAs is the ability for raw material manufacturers to disclose confidential information directly to the FDA without the need to disclose to manufacturers or brand owners. The compilation of an effective TPMF involves deploying best practices from a Drug Master File, the pharmaceutical equivalent document. This approach allows clients to regulatory update and maintain their TPMF without having to burden the manufacturer.

A key requirement of MRTPAs and a recommended action for PMTA is that of post-marketing surveillance (PMS). PMS involves the proactive collection of data once a product has been placed on the market in order to determine the relative safety of the product and its continued Appropriateness for the Protection of Public Health (APPH).

For MRTPAs, PMS is a mandatory requirement with a further duty to submit annual reports to FDA in relation to PMS. Inter Regulatory is positioned to advice and assist in the development of PMS plans and for the collation and reporting of PMS data to FDA on an annual basis per conditional Orders issued by FDA.

Our inhouse qualified Lead Auditors can offer support to ensure that our clients become and remain compliant with industry best practices. In the absence of a Federal definition of Good Manufacturing Practice for ENDS and HTPs, Inter Regulatory adopts a hybrid approach of implementing current GMP, ISO 9001 and ISO 13485 to ensure product quality and consistency.

For established manufacturers, it is recommended to conduct a gap analysis through internal audit in order to determine the organizations current compliance status and to identify any areas of improvement prior to FDA inspection.