Regulatory Affairs
From Concept to Plan
Zwiers integrates regulatory intelligence information and health authority requirements into sound strategy, ensuring that requirements in the complex regulatory framework will be met.
- Scientific advice
- Long term strategy plans
- Orphan drug designations
- Pediatric investigation plans
- Regulatory writing
- Competitor analysis
- (pre) Clinical development plans
Defining the right strategy is a matter of obtaining the relevant information, analysing and interpreting it and ensuring incorporation in project management planning. We do it for you; we’re good at it!
Smoothen the regulatory pathway?
Meet with Zwiers! Contact us
From Aim to Action
Zwiers Regulatory Consultancy maintains the product lifecycle. From the very start until well after approval.
- Legal entity changes
- Manufacturing changes
- CTAs/INDs
- Due diligence
- Variations, labelling changes
- Post-approval commitments
Coordination is key! Executing regulatory goals and fulfilling requirements can put a large burden on your resources. We reduce this burden by taking over all activities and handling regulatory procedures.
Maximise Your Product’s Potential?
Meet with Zwiers! Contact us
From Document to Dossier
(e)CTA? eIND? IMPD? eCTD for new NDA/BLA/MAA? for variation/extension/supplement?
We make sure you’re submission ready! We write, review, hyperlink, QC, compile and submit in line with regulatory guidelines.
- Writing and Review
- Module 1; region specifics, product information
- CMC/Quality (M2.3 QOS, M3)
- Preclinical (M2.4, M2.6 tabulated and written, M4)
- Clinical (M2.5 overview, M2.7 summaries, M5), including CSRs – see Navigating CSR types for optimal reporting of trial results
From Question to Advice
All meetings – e.g. scientific advice, pre-IND, EOP, pre-submission – with regulatory health authorities require preparation, whether they are of a scientific or a regulatory nature, with a national or a central agency and regardless of the product lifecycle phase.
We provide:
Advice
We help decide on the strategy of approaching regulatory health authorities and which questions to ask
Documentation
We compile meeting packages including writing of all necessary documentation
Coaching
We train your meeting delegates to ask the right questions and to obtain relevant answers
Responses
We use our regulatory expertise to interpret regulatory health authority requests and adequately address them in a timely manner. If you need our help with any of the above, please contact us
From Product Profile to Patient Leaflet
SPC, CCDS, PIL? An efficient Labelling Officer with writing and organisational skills will deliver compliant texts in time.
Our talent is highly qualified to do the job
From Molecule to Medicine
Do you have a promising compound ready for development?
Do your shareholders want to see a sound plan to bring it to the market?
Zwiers Regulatory Consultancy takes a special interest in helping start ups to increase chances of success.
Strategy
We will discuss regulatory possibilities and challenges with you and present the results in a regulatory strategy plan. As discussions with the health authorities will also play an important part in the strategy, we will advise on when and how to approach health authorities.
Opportunities
Your drug in development may be very promising. You may be using a highly innovative technology. You may intend to serve a specific population. Or to treat a neglected or rare disease. Or maybe your product is in another way distinctively different from regular therapies. Because of its unique profile, the regular regulatory guidance may not apply or there may be a smart marketing authorization route. We will explore alternative pathways for you.
Examples are:
- accelerated review
- orphan drug status designation
- WHO prequalification
- Article 58 procedure
- paediatric-use marketing authorizations
- biosimilar regulatory pathways
- compassionate use
- specific pathways for medical devices and combination products
- actions
Not only do we provide you with strategic advice, we actually execute the plan. We prepare all documentation, e.g. clinical trial applications, target product profiles, requests for specific procedures, meeting packages and, ultimately, the application dossiers.
Need support for your start up project?
Please contact us.
We have offices in Oss and Amsterdam
Zwiers Regulatory Consultancy is a ProductLifeGroup Company
ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.
