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 with the technical know-how and competence needed to handle registration documents associated with product development and approval including:
• Product Dossiers
• Drug Master Files
• Site Master File
• Marketing Authorizations (NAFDAC (Nigeria), FDB (Ghana))
• Product Registration Renewal
• Risk Management Plan
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.
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.
Product Approval Strategy
ASA-SANTHILL is equipped with the technical know-how and competence needed to handle registration documents associated with product development and approval including:
• Product Dossiers
• Drug Master Files
• Site Master File
• Marketing Authorizations (NAFDAC (Nigeria), FDB (Ghana))
• Product Registration Renewal
• Risk Management Plan
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.
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.
West Coast Regulatory Intelligence
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.
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.
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.
Our Research is Designed to provide the client with:
• Current registration requirements in specified countries
• Source of relevant legislation be obtained
• Relevant guidelines
• Current application fees
• Language requirements of specific countries
• Timeline for the registration process
• The appropriate contact(s) at the authorities
• Prevailing attitude towards a particular product type
• Technical Document acceptable to a country
• Local procedure for obtaining reimbursement
• The mechanism for pricing approval
• Effect of local harmonization efforts on marketing strategy
• Requirements for making submission
• Does my product need to be registered?
• Product Classification
• Special considerations apply to borderline products
• Similar products on the market, if any
• If available special procedure for herbal products
• Compliance of product label
• Appropriate clinical development strategy
• Patent restrictions if any
• Local manufacturer or distributor
• Centres for local clinical trials
• If available, local agent who can liaise with the authorities
• Do you have translation capabilities?
• Availability of a raw material • Available safety data on a product
• Local differences in medical practice
• Changes expected in the coming years
Documentation
Effective documentation is necessary for timely marketing authorization of any regulated product.
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.