{"id":21664,"date":"2021-04-21T15:08:18","date_gmt":"2021-04-21T15:08:18","guid":{"rendered":"http:\/\/anthillglobal.co.uk\/new\/?page_id=21664"},"modified":"2025-09-13T18:33:53","modified_gmt":"2025-09-13T18:33:53","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/asasanthill.com\/index.php\/regulatory\/","title":{"rendered":"Regulatory"},"content":{"rendered":"\t\t
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Regulatory Services<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Submission Management<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ASA-SANTHILL is staffed with seasoned professionals who provide regulatory expertise at all stages of product idea development with a view to enhancing submission preparations and achieving faster product approval\/market authorization.<\/p>

We employ key staff who have more than 15 years practical experience in product development and regulatory affairs.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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ASA-SANTHILL is equipped with the technical know-how and competence needed to handle registration documents associated with product development and approval including:<\/p>

\u2022 Product Dossiers
\u2022 Drug Master Files
\u2022 Site Master File
\u2022 Marketing Authorizations (NAFDAC (Nigeria), FDB (Ghana))
\u2022 Product Registration Renewal
\u2022 Risk Management Plan<\/p>

Since the purpose of any regulatory submission is to get successful marketing authorization, submitting the right documents and appropriate response to agency queries is crucial to timely completion of any product registration project.<\/p>

We assist our clients to interpret technical queries and provide prompt and adequate response to all the issues raised in a query, thus facilitating document processing for product marketing authorization.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Product Approval Strategy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ASA-SANTHILL is equipped with the technical know-how and competence needed to handle registration documents associated with product development and approval including:<\/p>

\u2022 Product Dossiers
\u2022 Drug Master Files
\u2022 Site Master File
\u2022 Marketing Authorizations (NAFDAC (Nigeria), FDB (Ghana))
\u2022 Product Registration Renewal
\u2022 Risk Management Plan<\/p>

Since the purpose of any regulatory submission is to get successful marketing authorization, submitting the right documents and appropriate response to agency queries is crucial to timely completion of any product registration project.<\/p>

We assist our clients to interpret technical queries and provide prompt and adequate response to all the issues raised in a query, thus facilitating document processing for product marketing authorization.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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West Coast Regulatory Intelligence<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ASA-SANTHILL has a network of local representatives in all the major territories of West Africa. All speak the local language and can advise on local regulations in their country, as well as the current attitudes prevailing within their national regulatory body.<\/p>

Geographically, West Africa comprise 16 countries distributed over an area of approximately 5 million sq. meters, with a population of about 300 million people representing 4.6% of the world population. All the 16 countries except Mauritania are members of Economic Community of West African States (ECOWAS). ASA-SANTHILL Consulting Company can operate in 15 ECOWAS states. Our West Coast (Africa) regulatory intelligence service can identify and advise on local regulations and provide national input into regulatory projects.<\/p>

Our regulatory intelligence service is designed to provide up-to-date guidance on local regulatory requirements for marketing authorization of both novel and existing pharmaceuticals, high tech products as well as devices and allied products.<\/p>

Our Research is Designed to provide the client with:<\/strong><\/p>

\u2022 Current registration requirements in specified countries
\u2022 Source of relevant legislation be obtained
\u2022 Relevant guidelines
\u2022 Current application fees
\u2022 Language requirements of specific countries
\u2022 Timeline for the registration process
\u2022 The appropriate contact(s) at the authorities
\u2022 Prevailing attitude towards a particular product type
\u2022 Technical Document acceptable to a country
\u2022 Local procedure for obtaining reimbursement
\u2022 The mechanism for pricing approval
\u2022 Effect of local harmonization efforts on marketing strategy
\u2022 Requirements for making submission
\u2022 Does my product need to be registered?
\u2022 Product Classification
\u2022 Special considerations apply to borderline products
\u2022 Similar products on the market, if any
\u2022 If available special procedure for herbal products
\u2022 Compliance of product label
\u2022 Appropriate clinical development strategy
\u2022 Patent restrictions if any
\u2022 Local manufacturer or distributor
\u2022 Centres for local clinical trials
\u2022 If available, local agent who can liaise with the authorities
\u2022 Do you have translation capabilities?
\u2022 Availability of a raw material \u2022 Available safety data on a product
\u2022 Local differences in medical practice
\u2022 Changes expected in the coming years<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Documentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Effective documentation is necessary for timely marketing authorization of any regulated product.<\/p>

The key staff at ASA-ANTHILL with vast experience in Pharma and Food manufacturing, Quality control and Product development research, provide expert service in technical writing for Pharmaceuticals and allied products. With their wealth of experience, they are able to bring out the scientific content in a regulatory document in line with the agency expectations.

ASA-SANTHILL offers complete dossiers compilation and submission services. We guide our clients to ensure that every document for submission is in line with the local agency requirement. This we achieve by vetting every document before final copies for agency submission are printed. Our office facilities are designed to enable effective compilation of documents, high speed printing and copying of regulatory documents. All clients’ documents are handled with strict confidentiality.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Regulatory Services Submission Management ASA-SANTHILL is staffed with seasoned professionals who provide regulatory expertise at all stages of product idea development with a view to enhancing submission preparations and achieving faster product approval\/market authorization. We employ key staff who have more than 15 years practical experience in product development and regulatory affairs. ASA-SANTHILL is equipped […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-21664","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/pages\/21664","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/comments?post=21664"}],"version-history":[{"count":38,"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/pages\/21664\/revisions"}],"predecessor-version":[{"id":22227,"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/pages\/21664\/revisions\/22227"}],"wp:attachment":[{"href":"https:\/\/asasanthill.com\/index.php\/wp-json\/wp\/v2\/media?parent=21664"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}