Regulatory Affairs Services Provider in Switzerland
Switzerland is one of the most respected and tightly regulated life sciences markets globally, known for its strong regulatory independence, scientific rigor, and high compliance expectations. Successful life sciences product registration in Switzerland requires a thorough understanding of Swissmedic regulations, national procedures, and Switzerland-specific regulatory pathways, which operate separately from the European Union.
At DDReg, we provide specialized Regulatory Affairs Services in Switzerland, supporting global and local pharmaceutical, biotechnology, and medical device companies with market entry, product registration, and full lifecycle regulatory compliance. With hands-on experience across Swissmedic submissions, DDReg acts as a trusted Regulatory Affairs Consultant in Switzerland, delivering precise, authority-aligned regulatory solutions.
Understanding the Regulatory Affairs Process in Switzerland
Regulatory oversight in Switzerland is managed by Swissmedic, the Swiss Agency for Therapeutic Products. Swissmedic is responsible for regulating pharmaceuticals, biologics, and medical devices under Swiss national legislation, while maintaining alignment with international standards such as ICH.
Swissmedic is responsible for:
- Authorization of human and veterinary medicinal products
- Oversight of clinical trials and investigational medicinal products
- Regulation of medical devices under Swiss Medical Devices Ordinance (MedDO)
- Supervision of GMP, GDP, and GCP compliance
- Pharmacovigilance, materiovigilance, and post-market surveillance
As an experienced Swissmedic Regulatory Consultant, DDReg supports clients throughout the regulatory affairs process in Switzerland, ensuring submissions meet current Swissmedic requirements and review expectations.
Our Regulatory Expertise in Switzerland
DDReg offers end-to-end regulatory consulting services in Switzerland, customized for multinational and regional organizations. Our approach combines local Swiss regulatory intelligence with global regulatory best practices, enabling efficient approvals and sustained compliance in the Swiss market.
We work closely with Swissmedic requirements to minimize regulatory delays, address authority queries effectively, and support long-term market access.
Our Regulatory Affairs Consulting Services in Switzerland
- Product classification and Swiss regulatory compliance mapping
- Pre-submission regulatory planning and readiness assessments
- Preparation, publishing, and submission of dossiers (CTD / eCTD formats)
- Pharmaceutical regulatory affairs in Switzerland
- Drug regulatory consulting in Switzerland for new drugs, generics, and variations
- Medical Device Registration in Switzerland under Swiss MedDO
- Technical documentation, performance evaluation, and compliance mapping
- Labeling, IFU, and packaging review (German, French, or Italian requirements)
- Authorized local representative and regulatory representation support
- Coordination and regulatory liaison with Swissmedic
- Gap analysis and regulatory remediation planning
- Lifecycle management, including renewals, variations, and post-approval changes
- Regulatory query handling and deficiency response management
- Post-market regulatory compliance, vigilance, and change control
- Ongoing local regulatory intelligence and monitoring of Swiss regulatory updates
As a specialized Switzerland Regulatory Consulting Firm, DDReg delivers structured, regulator-ready regulatory execution.
Why Choose DDReg as Your Regulatory Affairs Consultant in Switzerland?
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Swissmedic Focused Regulatory Expertise
Our consultants have deep knowledge of Swissmedic procedures, national regulatory expectations, and submission practices. -
Local Execution with Global Regulatory Alignment
We support Switzerland-specific regulatory requirements while maintaining alignment with ICH and international standards. -
Strategic Regulatory Partner in Switzerland
DDReg is more than a service provider; we act as a long-term regulatory partner, supporting lifecycle compliance, risk mitigation, and sustained market access.
Industries We Support in Switzerland
- Pharmaceutical and Generic Drug Manufacturers
- Biotechnology and Life Sciences Companies
- Medical Device and Diagnostics Manufacturers
- Combination Products and Advanced Therapies
- Companies entering or expanding in the Swiss market
Our Regulatory Affairs Consulting Services in Switzerland portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
