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Safety and Risk Management
Safety Consulting
Pharmacovigilance
Aggregate Reporting and Safety Writing
Pharmacovigilance
Safety and Risk Management

Safety and Risk Management

Delivering drug safety services from case intake to case processing and submission

Delivering end-to-end regulatory compliance for drug safety

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Scientific Medical Writing

Delivering drug safety services from case intake to case processing and submission

Delivering end-to-end regulatory compliance for drug safety

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Publication Support Services

Delivering drug safety services from case intake to case processing and submission

Delivering end-to-end regulatory compliance for drug safety

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Safety and Risk Management

Delivering drug safety services from case intake to case processing and submission

Delivering end-to-end regulatory compliance for drug safety

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Safety and Risk Management

Delivering drug safety services from case intake to case processing and submission

Delivering end-to-end regulatory compliance for drug safety

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Safety and Risk Management

Delivering drug safety services from case intake to case processing and submission

Delivering end-to-end regulatory compliance for drug safety

Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasingly capitalizing on outsourcing services to enable focused excellence on their core business.

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

A partnership

built on trust

Find out how our people, processes and culture of quality come together to make sure that work flows smoothly and consistently, always.

A partnership

built on trust

Find out how our people, processes and culture of quality come together to make sure that work flows smoothly and consistently, always.

A partnership

built on trust

Find out how our people, processes and culture of quality come together to make sure that work flows smoothly and consistently, always.

EXPERTISE FIELD

Regulatory affairs for medical devices

The medical device regulations are becoming increasingly difficult. It will be hard to deal with the changed requirements for medical device regulatory compliance.

You might have experienced this in your latest audits or submissions. Regulatory compliance has always been around, it now simply pushed to a new and higher level. That has implications for your RA, QA and Clinical Department.