Global Regulatory Governance
PharmaConsult is uniquely positioned to ensure that your products meet all regulations and laws no matter where you are or where you require the product to be registered. Our teams have successfully managed multiple large-scale projects through to the post-market phase. We can position you for success from the initial development of new medicines all the way through to market readiness. We can provide advice on product formulation, indications and dosage instructions.
Work begins as soon as a new drug is discovered and continues long after product reaches pharmacy shelves. Stringent testing requirements have to be met which include accurate and detailed information along with convincing analysis and results.
Before documentation is submitted, it's down to regulatory affairs to ensure the right tests have been done at the right times - and with the correct interpretation of results.
Even when a licence to sell a new treatment has been granted, work doesn't end there. It's important to ensure a medicine's packaging is accurate and informs patient about benefits and potential drawbacks.
We'll manage implementation of responsible labelling and packaging to ensure new treatments are effective, have minimal risks and quickly reach your market.
Good labelling can safeguard against drug misuse and prevent dangerous side effects. Accurate labelling can be as much a lifesaver as the drug itself.
Electronic Document submission
Many Regulatory Authorities will now only accept electronic-only submissions with eCTD. This applies to both new and existing submission types. Paper and other (non-eCTD) electronic formats will only be received as an exception PharmaConsult will assist you in preparing your own eCTD dossier by providing;
- Regulatory support during pharmaceutical development, preparing CTD-ready documentation(CMC, Clinical, Non-clinical, labelling)
- Development, preparation, assembly and submission of complete CTDs/MAAs for Europe and USA registration
- Preparation of responses to regulatory authorities, comment letters, and assessment reports
Regulatory due diligence
Regulatory due diligence can be undertaken for potential licensing opportunities. Not only can we identify gaps in old dossiers, but we can arrange for and manage the additional studies to complete the dossier. And we’ll prepare the following documents on behalf of our clients:
- Briefing documents for pre-NDA or EMA scientific meetings
- Expert reports: CTD pharmaceutical, preclinical or clinical overviews.
- Mutual Recognition response documents
Contact us for a review of your needs to provide you with the most appropriate service model for your project.
- Authority Communication
- Classification of Changes
- CMC and Medical Writing for Development
- CMC and Medical Writing for Submission
- Customer On-Site Support
- Dossier Preparation, Submissions & Approvals
- Drug Product (production, formulation, and scale up)
- eCTD Consultancy
- eCTD Publishing all formats
- Global Regulatory Strategy
- IND/ IMPD Compilation and Submission
- Labelling/PI/CCDs Management Globally
- Marketing / Labelling Activities
- Processing & Submission of Marketing Authorization Application
- Processing of Clinical Trial Application (CTA)
- Regulatory Intelligence
- Rx to OTC Switch
- Scientific Advice / Pre-Submission Meetings
- Second Wave Submissions/ Global Roll Outs
- Technical CMC / Medical Writing & Dossier Updates
- Technical Support for CMC / Quality