2.01
Regulatory submissions
- INDs and CTAs
- NDAs, BLAs, and MAAs
- CTD and eCTD module preparation
- Submission strategy and content planning
- Gap analysis of existing dossiers
Regulatory · Clinical · Scientific communications
Science is only as strong as the document that describes carries it.
ECS Bioconsulting writes the submissions, protocols, reports, and manuscripts that move drugs, biologics, and devices through review, and runs the programs that keep them on schedule.
Capability statementRev 2026
- Practice
- Medical writing and program management for life sciences
- Scope
- IND through post-market, small molecule to Class III device
- Agencies
- FDA, EMA, and national authorities; EU MDR
- Status
- Accepting new engagements
01
The practice
ECS Bioconsulting sits between your data and the people who have to act on it: reviewers, investigators, ethics committees, notified bodies, and prescribers. We turn clinical, nonclinical, and technical evidence into documents that hold up under scrutiny.
Every deliverable is written by someone who understands the underlying science and the format the receiving agency expects. That means fewer review cycles, cleaner responses to queries, and a submission narrative that stays consistent from protocol through label.
We work as an extension of your team, not a black box. You see outlines before drafts, comment resolution logs after every review, and a schedule that names the day each document lands.
Engagement models
- Single document
- One protocol, CSR, CER, or manuscript, scoped and priced up front.
- Program support
- A named writer across a full submission or study series.
- Embedded
- Fractional writing or program management capacity inside your team.
- Review only
- Independent scientific QC and editorial review of documents you drafted.
02
Medical writing
2.02
Clinical documentation
- Study protocols and amendments
- Clinical study reports
- Investigator brochures
- Informed consent forms
- Case report form development
- Clinical overviews and summaries
2.03
Safety and pharmacovigilance
- PSURs and PBRERs
- Development safety update reports
- Risk management plans
- REMS documentation
- Aggregate reports and safety narratives
2.04
Medical device files
- 510(k) premarket notifications
- Premarket approval applications
- EU MDR technical documentation
- Clinical evaluation reports
- Software as a Medical Device files
- Post-market clinical follow-up plans
2.05
Scientific communications
- Peer-reviewed manuscripts
- Congress abstracts and posters
- Slide decks and scientific platforms
- White papers and position statements
- Medical education content
- Advisory board and expert meeting reports
2.06
Agency correspondence
- Briefing books for agency meetings
- Scientific advice requests
- Responses to information requests
- Orphan drug designation applications
- Fast track and breakthrough requests
03
Program management
3.01
Clinical programs
- Study startup through database lock
- Timeline build and milestone tracking
- Cross-functional coordination
- CRO and vendor oversight
- Budget tracking and forecasting
- Risk registers and mitigation plans
3.02
Submission programs
- Submission planning and content tracking
- Agency meeting preparation
- Authoring and review calendars
- Global filing sequencing
- Publishing handoff coordination
3.03
Device programs
- Design control documentation
- EU MDR transition projects
- ISO 14971 risk file coordination
- Usability and human factors studies
- Software lifecycle documentation
3.04
Strategic consulting
- Development program planning
- Regulatory pathway options
- Due diligence document review
- Portfolio and resource prioritization
- Competitive and label benchmarking
04
How a project runs
Stage 01
Scope
We agree on the document, the source data, the reviewers, and the date it has to be final. You get the schedule in writing before work starts.
Stage 02
Outline
An annotated outline fixes structure, key messages, and table shells early, so structural comments arrive before the prose is written.
Stage 03
Draft
Writing against the agreed outline and the applicable guidance, with data traced back to source tables, listings, and figures.
Stage 04
Review
Consolidated comment rounds with a resolution log, so every reviewer can see how their comment was handled and why.
Stage 05
QC and release
Independent quality control against source, style guide, and format requirements. You receive a clean file and its QC record.
05
Sectors served
05.1
Pharmaceutical
Small molecules, biologics, and biosimilars, from first-in-human through lifecycle management.
05.2
Biotechnology
Novel therapeutics, cell and gene therapy, and platform programs with evolving regulatory precedent.
05.3
Medical devices
Class I through III devices, implantables, diagnostics, and drug-device combination products.
05.4
Digital health
Software as a Medical Device, digital therapeutics, and AI and machine learning based tools.
05.5
CROs and service partners
Overflow writing capacity, independent QC, and regulatory support during peak workload.
05.6
Academic and translational
Investigator-initiated trials, grant-linked documentation, and technology transfer support.
06
Coverage
Therapeutic areas
- Oncology and hematology
- Cardiovascular and metabolic disease
- Central nervous system disorders
- Infectious disease and vaccines
- Rare disease and orphan programs
- Immunology and inflammation
- Respiratory and pulmonary medicine
- Dermatology and aesthetic medicine
Device categories
- Cardiovascular devices, including stents and valves
- Orthopedic and spinal devices
- Neurological devices and neurostimulation
- Diagnostic and imaging equipment
- Surgical and interventional devices
- Ophthalmic devices
- In vitro diagnostics
- Software as a Medical Device and AI tools
07
Contact
Tell us what has to be filed, and when.
Most projects start with a short call and a look at your source material. Bring whatever you have; a protocol synopsis and a target date are enough to scope the work.
- ProgramMolecule or device, stage of development
- DocumentWhat needs to be written, reviewed, or rescued
- DateThe deadline that cannot move
- SupportWho reviews, and who signs off
- Confidentiality
- Mutual NDA before any source material is shared.