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Regulatory Affairs Services

Providing you the best range of CTD/ACTD/eCTD Regulatory Dossier Preparation Services, ASEAN CTD (ACTD) Dossier Preparation Services, Drug Master File (DMF) Preparation Services, Standard Operating Procedure (SOP) Preparation Services, Common Technical Document (CTD) Dossier Preparation Services and Site Master File (SMF) Preparation Services with effective & timely delivery.

CTD/ACTD/eCTD Regulatory Dossier Preparation Services
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We provide Regulatory Dossier Services for following countries in

CTD/ACTD/e-CTD/Country-specific/Region-specific Formats:

Asia including ASEAN Countries
African Countries
Latin and Central American Countries
CIS Countries
Middle East Countries

We also provide Regulatory Services for eCTD Dossier Submission and Support Services for
USA, Canada, Europe, S.Africa, GCC and Australia/New Zealand.

For specific customized services please contact us for best prices.

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ASEAN CTD (ACTD) Dossier Preparation Services
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We provide ASEAN CTD Dossier Preparation Services for Product Registration in following ASEAN Countries:

- Brunei
- Cambodia
- Indonesia
- Laos
- Malaysia
- Myanmar
- Philippines
- Singapore
- Thialand
- Vietnam

Please send an enquiry for best service and competitive quotation.

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Drug Master File (DMF) Preparation Services
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Drug Master File (DMF) Preparation Services

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Minimum Order Quantity: 1 Piece

We provide Drug Master File (DMF) Preparation Services for Regulatory Dossiers and Regulatory Submission. Drug Master File as per CTD Format Drug Master File Submission in eCTD Format for USA, Europe, Canada, ANZ, SwissMedic, GCC and S.Africa. We provide Drug Master File Preparation Services at competitive rates.

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Standard Operating Procedure (SOP) Preparation Services
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We provide Standard Operating Procedure (SOP) Preparation Services.

Please send an enquiry for best service and competitive quotation.

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Common Technical Document (CTD) Dossier Preparation Services
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We provide Common Technical Document (CTD) Dossier Preparation Services for 

- Asia including ASEAN Countries
- African Countries
- Latin and Central American Countries
- CIS Countries
- Middle East Countries

Please send an enquiry for best service and competitive quotation.

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Site Master File (SMF) Preparation Services
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We provide Site Master File (SMF) Preparation Services for

- Pharmaceutical Industries
- Medical Devices Industries
- Surgical Products Industries
- Nutraceutical Industries
- Cosmetics Industries

Kindly send an enquiry for best service and competitive quotation.

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Periodic Safety Update Report (PSUR) Preparation Services
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We provide Periodic Safety Update Report (PSUR) Preparation Services.

Please send an enquiry for best service and competitive prices.

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