Explore SPharm’s Regulatory Services

Effective management of drug development plans, Clinical Trial Applications and marketing authorizations require thorough knowledge of current regulations and an excellent product development strategy.

Our expertise goes beyond the scope of simply providing health product regulatory consultation and dossier preparation. SPharm provides the advantages of a true partnership by ensuring that its experience and services are fully integrated with your company’s internal procedures and strategic objectives that ultimately save you time and money.

Regulatory

Regulatory submissions
Lifecycle management for drugs and medical devices
Complementary services

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Product Development

Due diligence
Strategic health product development
Brand name analysis

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Pharmacovigilance

Clinical trials and Post-marketing surveillance programs
Risk Management Plans (RMP)
Pharmacovigilance training

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Compliance and Quality

Quality due diligences
Drug Master Files (DMF)
Establishment Licences (EL)

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Services through our partners

Foreign regulatory affairs
Ethics Review Board
In vivo nonclinical studies
Monitoring of Clinical Studies
Clinical trial report writing
Statistical analysis

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Training & Consulting Services

Spharm provides training services to individuals and organizations to enable a practical understanding of the drug regulatory approval processes.

We offer both custom and standard training sessions. Learn more about some of the modules we cover in our training.

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