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Functional activities of Regulatory Affairs Professional in industries

Activities of Regulatory Affairs

Dedicated Regulatory Procedures Team

At the heart of everything we do is regulatory affairs. We understand our clients’ need for their products' route to market to be as smooth as possible: this requires us to have the relevant EU regulatory knowledge at our fingertips, so that we can advise on the optimum regulatory pathway to follow, and ensure that your technical documentation conforms with the relevant guidelines and meets the required standards. From the earliest stages of drug development all the way through to dossier submission and post authorization life cycle management, all work carried out by every employee at TPRAC is in the context of the regulatory requirements. The work of TPRAC’s dedicated regulatory procedures team can be categorized as shown in the panel to the right. Follow the links to find out more about how our team can support your regulatory department, whether that means assisting with specific projects or working more closely with your company

Our technical teams

The regulatory procedures team also acts as the hub from which the work of our technical teams, for pharmaceuticals and immunologicals, is coordinated in preparation for regulatory submissions. Communicating progress and timelines internally, with our clients and their business partners facilitates efficient working practices and allows for crucial project deadlines to be met.

Scientific writing for dossiers and reports

• Preparation of the dossier sections for the administrative and summary parts, and the quality, safety and efficacy documentation (Parts 1, 2, 3A, 3B and 4)
• Detailed and Critical Summaries (DACS, previously Expert Reports), including tabular summaries for Parts 2, 3A, 3B and 4
• Preparation of Expert Reports and Statements to support renewals, variations and line extensions
• Preparation of responses to questions during the assessment process
• Risk Benefit Assessments

Expert representation at authority meetings and oral explanations

• Pre-submission meetings and negotiations with the Competent Authorities to discuss technical aspects of data to be submitted
• Expert support for oral hearings and referrals
• Scientific Advice and Innovation Task Force briefing documents
• Provision of advice and support relating to MUMS classification and applications

Marketing Authorisation Applications and other regulatory submissions

TPRAC has prepared and submitted dossiers for full, bibliographic, generic, hybrid and informed consent applications, for a wide array of different veterinary medicinal product (VMP) types and pharmaceutical forms. As well as initial MAA procedures, TPRAC has experience of line extensions to add new species, new indications, and new strengths/formulations to existing MAs. Our teams are fully equipped to handle all other types of post-marketing applications too. For some of our clients, we act as a ‘regulatory arm’ or supplementary team member, and handle all of the routine work relating to their animal health portfolio. Refer to our life-cycle management section and key person cover service to find out more.
The kinds of work we routinely support our clients with are listed below: • Marketing Authorisation Applications (MAA) via Centralised, Mutual Recognition, Decentralised and National Procedures
• Variations, Line Extensions, Renewals and MA Transfers (see life-cycle management)
• Maximum Residue Limits submissions (MRL dossiers)
• Scientific Advice requests
• Periodic Safety Update Reports (PSURs)
• Clinical Trial applications
• Feed Additive dossiers, including compound feeds, PARNUTs, and zootechnical products (see Feed and Feed Additives)
• Borderline product assessment applications
• Minor Use Minor Species (MUMS) applications
• Preparation of ASMF / DMF / EDMF dossiers
• Preparation of CEP applications and updates

Regulatory intelligence & strategic planning

Development and marketing strategies
TPRAC understands the important roles regulatory intelligence and strategic planning play in effective and swift authorisation of veterinary medicines and other animal health products. Whatever stage your project is at, we can add value through expert advice on product development strategy - through the authorisation process, and beyond.

A regulatory consultancy you can rely on

The management of a European dossier submission process can become complex with translations into official EU languages, national administrative requirements and authority fee payments. TPRAC can manage the complete dossier submission process via all required routes (CP, MRP, DCP, NP) and can act as point of contact with the National Competent Authorities, managing the regulatory procedure on your behalf, allowing you to use your time resources elsewhere.
TPRAC’s team can organise all pre-submission actions, prepare responses to authority questions during the procedure itself (LoQ), liaise with EU authorities to ensure that assessment timelines are rigidly adhered to and complete all national requirements (such as linguistic review and checking compliance for mock-ups of the labelling and packaging) to ensure your product gets to market on time. Having wide-ranging language capabilities (please refer to our Contact Page) can also be an asset to your company. You don’t need to be a linguist to benefit from our skills either: we find that communicating with the regulators is greatly facilitated by speaking their language.
Our effective project organisation, coupled with excellent communication, means that our clients are kept fully informed of their projects’ progress, and puts them in control of their submissions at all times.

Strategy for the EU, and for Global Markets

A clear understanding of the merits and limitations of all the regulatory options available allows TPRAC to identify the best regulatory strategy for your product, which meets with your budget and available resources. An appreciation of key differences in the authorization processes and data requirements between the main global markets allows us to highlight to our clients where they may encounter problems and how best to avoid them; understanding where the regulatory differences can work to the advantage of our clients is also one of our strengths. If you have global ambitions for your product, TPRAC is an ideal business partner. As part of the group, we have animal health capability in many key markets (see International Services), and through strategic collaboration with trusted partners in other regions we can support your product development and launch at a multi-national scale.
Apart from strategic planning for the consideration of cost, time and the overcoming of regulatory hurdles, the major benefit from our strategic support is the enhancement of marketability for your product compared to its competitors. Increased marketability can be achieved through: choice of viable reference products (for generics, considering the notion of a ‘global marketing authorization’), the most favorable SPC and labelling criteria, optimal distribution categories, etc.