Regulatory Affairs & Strategy
Strategic regulatory guidance and operational excellence across global markets. From early development through post-market surveillance, our regulatory experts navigate complex submission pathways to accelerate your product approvals and maintain ongoing compliance.
Strategic Regulatory Guidance for Global Markets
Our Regulatory Affairs team combines deep scientific expertise with comprehensive knowledge of global regulatory frameworks to deliver tailored strategies that maximise the probability of approval while minimising development timelines and costs. We provide end-to-end regulatory support from pre-clinical planning through post-market lifecycle management.
With hands-on experience across FDA, EMA, MHRA, PMDA, TGA, and Health Canada submissions, our team has the operational depth and strategic insight to guide sponsors through every stage of the regulatory journey — including first-in-human applications, pivotal trial designs, marketing authorisation applications, and post-approval variations.
Comprehensive Regulatory Services
Our regulatory affairs practice delivers end-to-end support across the full product lifecycle, from initial strategy development through post-market regulatory maintenance and health authority interactions.
Regulatory Strategy Development
Comprehensive global regulatory strategy aligned with your commercial objectives and development programme goals.
- Global regulatory strategy design
- Development pathway optimisation
- Accelerated pathway assessment
- Competitive landscape analysis
IND/CTA Submissions
Expert preparation and filing of investigational applications to initiate clinical trials across global markets.
- IND & CTA preparation
- IMPD authoring & compilation
- First-in-human applications
- Cross-reference letter management
NDA/BLA/MAA Submissions
Full marketing authorisation applications with expert eCTD publishing and lifecycle management support.
- Full marketing applications
- eCTD publishing & submission
- Lifecycle management
- Labelling negotiations
eCTD Publishing & Management
End-to-end electronic Common Technical Document assembly, validation, and publishing for regulatory submissions.
- Module 1–5 assembly
- Electronic submission publishing
- Regional format requirements
- Pinnacle 21 validation
Health Authority Interactions
Strategic preparation for and management of meetings and correspondence with regulatory authorities worldwide.
- Pre-IND meeting preparation
- Type A/B/C meeting management
- Scientific advice requests
- Protocol assistance procedures
Labelling & PI/SmPC Development
Regulatory-compliant product labelling, prescribing information, and summary of product characteristics authoring.
- Product labelling development
- Package insert authoring
- SmPC preparation & updates
- Global labelling harmonisation
Post-Market Regulatory Support
Ongoing regulatory maintenance including variations, renewals, and periodic safety reporting obligations.
- Variations & amendments
- Marketing authorisation renewals
- Periodic safety update reports
- Signal management support
Regulatory Compliance & Auditing
Proactive regulatory intelligence, compliance gap assessments, and inspection readiness programmes.
- Regulatory intelligence monitoring
- Compliance gap assessments
- Inspection readiness programmes
- Remediation action planning
Global Regulatory Coverage
Our regulatory experts maintain deep working knowledge of the requirements, expectations, and procedures of major health authorities across six key global markets.
FDA
United States
EMA
European Union
MHRA
United Kingdom
PMDA
Japan
TGA
Australia
Health Canada
Canada
Submission Types We Support
Our team has extensive experience preparing, publishing, and managing a wide range of regulatory submission types across therapeutic areas and development phases.
IND
Investigational New Drug
NDA
New Drug Application
BLA
Biologics License Application
MAA
Marketing Authorisation Application
ANDA
Abbreviated New Drug Application
510(k)
Premarket Notification
PMA
Premarket Approval
Why Choose MTK for Regulatory Affairs
Global Expertise
Deep regulatory knowledge across FDA, EMA, MHRA, PMDA, TGA, and Health Canada with proven track records of successful submissions in each jurisdiction.
Experienced Team
Senior regulatory professionals with decades of combined industry experience spanning pharmaceuticals, biologics, medical devices, and combination products.
Accelerated Timelines
Proven methodologies and submission templates that reduce preparation timelines without compromising quality, helping you reach market faster.
Integrated Approach
Seamless coordination between our regulatory, biostatistics, SAS programming, and data management teams for cohesive submission packages.
Discuss Your Regulatory Needs
Whether you are planning your first IND submission or managing a complex global regulatory portfolio, our team is ready to help. Contact us for a confidential discussion about your regulatory strategy and submission requirements.