consultancy in Drugs, Foods and Medical Devices Sectors, specialized in regulatory affairs of Ministry of Health –Oman and Gulf countries
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REGULATORY AFFAIRS SERVICES
Oman and MENA region drug market undergo rapid and constant transformation. As a result of this highly regulated and competitive market our network offers Regulatory Affairs services for medicinal products, medical devices, cosmetics and food supplements. Adwwaa Alwatania can ensure regulatory compliance as well as take care of your pre- and post-marketing needs. We provide a full scope of regulatory services -we investigate, strategize, manage and compile all necessary data for the on-going maintenance of a medicinal product.
We work on both Middle East and national levels to fulfil our clients’ expectations and demands for marketing authorisation applications, preparation and updating of SmPC, package leaflets and labelling, variations and renewals, readability and user testing and many more.
PHARMACOVIGILANCE
The ultimate goal of pharmacovigilance is to appropriately handle information concerning adverse drug reactions and to protect the public from emerging safety issues throughout a medicine’s lifecycle. We can offer national support in local Omani QPPV and Deputy on behalf of the clients. We will make sure that as marketing authorisation holder (MAH), you have the appropriate pharmacovigilance system in place, will examine the safety profiles of your medicines and will be in contact with the drug authority on your behalf.
MARKET ACCESS
The main objective of each Pharmaceutical company is to launch and distribute its products on one or several national markets. All Middle East markets have their own specificities regarding the distribution process, local representative needs, certification of medical representatives and applicable legislation at national level.
Adwwaa Alwatania network of companies can offer assistance to each Pharmaceutical company for launching products in ME countries:
- Assistance in creation of an affiliate Pharmaceutical company
- Recommendation and contacts with logistic partners
- Setting-up Technical Agreements with manufacturer/releaser or with logistic partners
- Certification of the sale forces and assistance for their supervising on a regulatory point of view regarding local legislation
HERBAL AND HEALTH PRODUCTS
- Study product compliance to Oman regulations and medications required
- Products classification in Oman MoH .
- Herbal / Health products registration.
- Labeling requirements and compliance .
- Health List registration .
- Warehouses SOPs and Auditing.
- CTF or eCTD files preparation, revision and evaluation.
VETERINARY PRODUCTS
- Study product compliance to Oman regulations and medications required.
- Products classification in Oman.
- CTD & eCTD Files preparation, revision and evaluation .
- Labeling requirements and compliance .
- Pricing and re-pricing systems .
FOOD PRODUCTS
- Study product compliance to Oman regulations and medications required.
- Products classification in Oman.
- CTD & eCTD Files preparation, revision and evaluation .
- Labeling requirements and compliance .
- Pricing and re-pricing systems .
- Herbal / Health products registration.
- Food products clearance.
COSMETIC PRODUCTS
- Study product compliance to Oman regulations and medications required.
- Labeling requirements and compliance .
- Cosmetic products clearance .
- New products for exclusive agency.
- Cosmetic System at Oman.
CONTINUOUS PHARMACEUTICAL EDUCATION (CPE)
Our training programme in continuous pharmaceutical education serve to update the practising pharmacist graduate knowledge in all matters-related patient care.
Our CPE will serve as the standard for maintaining professional competence for the pharmacist enrolled in the programme.
CLINICAL RESEARCH
We understand the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. As we are also a part of Clinical Research, we aim to produce accurate, reliable and statistically sound documents. Clinical Research is an integral part of the drug and diagnostics discovery and development process.
Before a new medicine or diagnostic test can be made available, evidence of its safety and effectiveness must be provided by well-designed, well-controlled, and carefully monitored clinical studies in patients consenting to participate.
- We can manage the clinical trials, collect their data and input patient information into electronic systems when required.
- Maintaining research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines.
- Recruit and screen potential study participants as per the protocol.
- Responsible for ensuring the study is in compliance with local and federal laws and regulations. Manages the inventory of equipment and supplies related to the study and orders more as
needed.
Questions? You’re covered.
This is achieved through Oman and MENA region network of independent service providers in regulatory affairs specialised in the field of medicinal products, medical devices, cosmetics and food supplements
The main objective of each Pharmaceutical company is to launch and distribute its products on one or several national markets. All Middle East markets have their own specificities regarding the distribution process, local representative needs, certification of medical representatives and applicable legislation at national level.