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Our service spans the development cycle of a product - from clinical development and licensing through to lifecycle maintenance in European and Emerging Markets. We support and guide your own creativity, fostering your ideas and shaping them into implementable plans. Focusing our insight and skills early in the product development cycle enables you to adjust your project planning and implementation for greatest efficiency and effect. We welcome your inquiries. Contact us.

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RegSafe Consulting Ltd

Habibullah Mazhar Thakur

37 A●●●●Road

Cam●●●dge , Cambridgeshire, CB23 6DJ

GB

44.7●●●●3747

do●●●●●●●●@hotmail.co.uk

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RegSafe Consulting Ltd

Habibullah Mazhar Thakur

37 A●●●●Road

Cam●●●dge , Cambridgeshire, CB23 6DJ

GB

44.7●●●●3747

do●●●●●●●●@hotmail.co.uk

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RegSafe Consulting Ltd – Home | regsafeconsulting.com Reviews

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Our service spans the development cycle of a product - from clinical development and licensing through to lifecycle maintenance in European and Emerging Markets. We support and guide your own creativity, fostering your ideas and shaping them into implementable plans. Focusing our insight and skills early in the product development cycle enables you to adjust your project planning and implementation for greatest efficiency and effect. We welcome your inquiries. Contact us.

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RegSafe Consulting Ltd – Home | regsafeconsulting.com Reviews

https://regsafeconsulting.com

Our service spans the development cycle of a product - from clinical development and licensing through to lifecycle maintenance in European and Emerging Markets. We support and guide your own creativity, fostering your ideas and shaping them into implementable plans. Focusing our insight and skills early in the product development cycle enables you to adjust your project planning and implementation for greatest efficiency and effect. We welcome your inquiries. Contact us.

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regsafeconsulting.com

1

RegSafe Consulting Ltd – Team

http://www.regsafeconsulting.com/team.html

Mazhar Hameed Thakur, MD. MBA. MAMM. BrAPP, PAPP, ICR, TOPRA. Mahgull Nazar Thakur, MD. BrAPP, PAPP, ICR,. Tanveer Z Mirza, MSc. Network of highly qualified professionals. Networking with KOLs and ex-Regulators. RegSafe Consulting Ltd maintains excellent networking with a range of key opinion leaders from major therapeutic areas across Europe and ex-regulators (FDA and EMA) to provide you with high level independent scientific advice and regulatory strategy support.

2

RegSafe Consulting Ltd – Links

http://www.regsafeconsulting.com/links.html

8226; European Union, European Medicine Agency (EMA). 8226; Japan, Ministry of Health Labour and Welfare. 8226; USA, US Food and Drug Agency (FDA). S Rest of the World (ROW). 8226; Argentina, ANMAT. Australia, Therapeutic Goods Administration (TGA). Canada, Health Canada. China, Ministry of Health. Hong Kong, Department of Health. India, Ministry of Health and Family Welfare. Israel, Ministry of Health. Malaysia, Drug Control Authority. Ministry of Health, Chile. Ministry of Health, Mexico.

3

RegSafe Consulting Ltd – Why us

http://www.regsafeconsulting.com/why_us.html

While we are fully familiar with the development patterns in different therapeutic areas, and adept at interpreting associated complex regulatory guidelines, we appreciate that every client needs a bespoke service that addresses their individual needs, organizational culture and unique product-specific concerns. We strongly believe that a custom-made approach to each development concern is the key to success. 8226; deep understanding of, and strong experience in, European and emerging markets. To discuss...

4

RegSafe Consulting Ltd – Services

http://www.regsafeconsulting.com/services.html

Regulatory affairs and Clinical development. Process and People development. Bull; Regulatory strategy. Bull; Regulatory project management. Bull; Regulatory documents preparation. Bull; Scientific Advice support. Bull; Qualification Advice/Opinion support. Bull; GAP analysis of submission packages. Bull; CTA/IND, MAA/NDA/BLA, Variations. Bull; Orphan/Compassionate use applications. Bull; Development strategy advisory panels. Bull; Study designs (interventional and observational). Bull; Due diligence.

5

RegSafe Consulting Ltd – Experience

http://www.regsafeconsulting.com/experience.html

Therapeutic areas of experience. Our consulting team has a strong track record of delivering high quality, successful projects for a range of clients from Top 10 pharmaceuticals to mid-sized biotech companies in several therapeutic areas. Non small cell lung cancer. Vaccines (HBV, H1N1, H5N1). Hepatitis (HBV, HCV). Overactive and neurogenic bladder. Inflammatory bowel disease (CD and UC). We welcome your inquiries. Contact us. To discuss how RegSafe Consulting Ltd can assist in ensuring your success.

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RegSafe Consulting Ltd – Home

Our service spans the development cycle of a product - from clinical development and licensing through to lifecycle maintenance in European and Emerging Markets. We support and guide your own creativity, fostering your ideas and shaping them into implementable plans. Focusing our insight and skills early in the product development cycle enables you to adjust your project planning and implementation for greatest efficiency and effect. We welcome your inquiries. Contact us.

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