TMC has extensive experience of global regulatory affairs and submissions, offering strategic advice and expert guidance from pre-approval through to post-approval phases.

We’ve built a trusted team of global experts offering word-class support. These experts work with and produce submissions to all major authorities worldwide, including, but not limited to, North and South America, the UK, Europe – both centrally via EMA and individual competent authorities – AsiaPac and major African countries.

Our comprehensive portfolio of regulatory services includes:

Pre–Approval, Marketing Authorisation Approval (MAA) & New Drug Approval (NDA)

Scientific Advice Procedures (Global Authorities)

We provide strategic reviews, prepare briefing packages and participate at authority meetings, e.g., EMA, FDA, MHRA, PMDA.

Clinical Trial Applications (CTA)

We review and validate data, perform gap analyses and prepare and submit applications on pre-clinical data worldwide. Additionally, we create and review investigational medicinal product dossiers (IMPD).

Mandatory Provision of Legal Representative for Clinical Trials

If a clinical study sponsor doesn’t have a local country office, we adopt the ‘legal representative’ role in the countries that require it, e.g., the EU, US and Australia.

Orphan Drug Designations (ODD)

We specialise in orphan and rare diseases and are proud to have written and submitted more than 200 successful ODD applications. If a clinical study sponsor doesn’t have a local country office, we can obtain and hold ODDs worldwide and run clinical trials quickly and efficiently to support pre- and post-approval marketing.

Paediatric Investigation Plans (PIP)

We’ve written and successfully negotiated more than 100 PIPs, which are a vital early step in the EU approval process.

New Drug Approval (NDA) Dossiers/Marketing Authorisation Approval (MAA) Dossiers

We can help clients compile whole dossiers, or just specialist elements, depending on a client’s requirements.

Common Technical Documents (CTD) Overview Summaries

We produce CTD summaries and overviews for clinical, non-clinical and chemistry/pharmacy parts of the dossier, using our international experts.

Post-Approval Regulatory Activities

Maintenance of Licences and Marketing Authorisation Variations

Acting as Local Marketing Authorisation Holder (MAH)

For products in transition of ownership, we can take the MAH role whilst partnering, or other activities, are underway.

Provision of Qualified Person for Manufacturing

For example for batch release and site audits.

Provision of Qualified Person for Pharmacovigilance (QPPV) and Post-Approval Safety Management

For authorised products.

Provision of Scientific/Medical Service

Our Medical team can provide the scientific/medical service to customers for marketed products.

Pharmacovigilance System Master File (PSMF)

Preparation and submission of PSMFs.

FDA, EudraVigilance & Other Territory Submissions

Suspected Unexpected Serious Adverse Reactions (USARs)

This includes medical reviews, periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and development safety update reports (DSURs).

Management of Extraordinary Regulatory Requirements

For example, in response to EU Article 31 procedures, product recalls etc.

Ensuring Compliance with the European Clinical Trial Regulation: Time is running out!

The European Medicines Agency’s (EMA) Clinical Trial Regulation (CTR) #536-2014 transition from the Clinical Trial Directive (CTD) 2001/20/EC has been a hot topic in the pharmaceutical industry for several years. As the January 2025 deadline is fast approaching, it is crucial for companies involved in clinical trials to take immediate action to ensure compliance, as failing to adapt to the new regulations could have severe consequences for ongoing trials and future drug development plans.

The European Commission (EC) and Member States (MSs) are strongly advising that the transition submission takes place before the 16th October 2024, to take advantage of the expedited procedure agreed by the Clinical Trials Coordination Group (CTCG), ensuring that the legislation is met within the timeline.

Adapting to the new regulations requires meticulous planning, coordination and regulatory expertise. Our customers can be assured of our experience and knowledge in navigating the CTR transition.

If you’d like to know more about how we can support the smooth transition, minimising any disruptions to ongoing trials and ensuring compliance with the CTR, please contact our team of regulatory experts today.

Get In Touch

Our team is ready and willing to support your regulatory needs.

To discuss your specific project requirements, contact us today.