Regulatory affairs support for submissions and changing rules.
Regulatory writing, submission preparation and EU MDR / IVDR support for pharmaceutical and medical device companies.
Regulatory work rewards precision and punishes delay. Stark Associates helps pharmaceutical, biotech and medical device teams prepare the documents and submissions that move products forward, and helps device and diagnostics manufacturers respond to the European Medical Device and In Vitro Diagnostic Regulations.
Regulatory writing
Our writers support clinical and nonclinical summaries and overviews, clinical study reports, protocols, investigator brochures and responses to agency questions. Each document is written to the relevant guidance, reviewed for consistency with source data, and delivered in the client's template.
Submission preparation
We help assemble and quality-check submission content, coordinate contributions from functional teams, and support electronic common technical document (eCTD) compilation and lifecycle management with the client's publishing tools or partners.
EU MDR and IVDR support
For device and diagnostics manufacturers selling into Europe, we support gap assessments against the regulations, technical documentation updates, clinical and performance evaluation documentation, post-market surveillance planning, and the preparation work that precedes notified body review. Final regulatory strategy and submissions remain the decision of the manufacturer and its notified body.
Regulatory staffing
When the need is for people rather than a project, we place regulatory specialists, writers and managers on contract or permanent terms. See talent and staffing.
How engagements work
We agree scope, deliverables and review cycles in writing before work begins, and keep version control and review history so every document is traceable.
When clients call us
Typical triggers include a submission deadline that internal writers cannot meet alone, a backlog of agency questions, a new product line entering Europe, or a notified body review that exposed gaps in technical documentation. In each case we start by agreeing what must be delivered, by when, and who signs off.
Drafts are shared early so reviewers can steer the content.
Drugs and biologics
- Regulatory dossier preparation
- eCTD publishing
- Regulatory labeling
- Medical writing
- Lifecycle management of dossiers
- Regulatory strategy and intelligence
Medical devices and IVD
- 510(k), PMA and technical file submissions
- Quality management system support
- Product quality complaints, post-market surveillance and health hazard evaluations
- EU MDR and IVDR reporting
- Labeling and UDI reporting
- Engineering support: design, supplier quality and validation