Afra Pharma Consultants (India)
Afra Pharma Consultant (APC) is a private limited company based in Pune, India, that was established in the 2011. We are a leading provider of quality resources for the regulation of pharmaceutical products including those deemed as consumer Health and OTC in India. The dedicated APC team is comprised of consultants with rich experiences in all aspects and at all levels of regulatory affairs in worldwide markets.
APC has a satisfied network of clients, situated throughout the Asian countries, North Africa, and India. The company provides a comprehensive range of services, including Training, PIL, Project Management, Audits and Inspections, and Strategic Planning. Tailored to the individual client’s requirements, the services are designed for Pharmaceutical Companies of all sizes.
APC strives to develop long-term relationships with clients, based on the highest levels of integrity, professionalism and trust. We are committed to doing business in an ethical and socially responsible manner.
“Expanding Consultancy Beyond Excellence"
REGULATORY & DOSSIER SUPPORT:
Our strength is a team of consultants with experiences ranging from 10-15 years in regulatory services in regulated and non-regulated markets, competence in Human medicines, Veterinary medicines, medical devices, Herbal drug and Dietary supplements.
Our Commitment to you is to provide total confidentiality; time bound submissions and regulatory support until the product is registered and marketed.
Dossier compilation as per:
- ASEAN Common Technical Dossier (ACTD) Guidelines
- South Africa (MCC-MRF-1) Guidelines
- Brazil ANVISA Guidelines
Dossiers (CTD) compilation for submissions in:
- Central America
- South America
- North America
Dossier compilation in Common Technical Dossier (CTD) format and Conversion to eCTD for:
- US FDA
- Saudi FDA
- European counties
DMF (Drug Master File):
We have associated with NABL Certified labs to carry out analytical testing.
We also perform the following studies as part of DMF prepaation:
- Structural Elucidation Studies
- Analytical Report (COA)
- Analytical Method Validation
- Process Validation
- Stability data studies
- Determination & Validation of Potential Impurities & Solvent Impurities
(All the data supported by necessary Chromatograms & Spectrums)
Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)
Dossier conversion (from one country to another)
We provide expert regulatory, clinical and compliance services to Pharmaceutical medical device manufacturers.
Our Services Include The Following:
- Preparation and submission of Regulatory documentation including
- Technical Files
- Design Dossiers
- Regulatory and Technical review and consulting
- Preparation and submission of registration for product applications
- Medical device vigilance and reporting systems
- Regulatory and manufacturing compliance
- Strategic and regulatory planning
- Regulatory/Quality GAP Analysis
- Interpretation of guidance documents and legislation
- Assistance with device labeling requirements
- Provide medical device classification
CLINICAL RESEARCH ORGANIZATION, BA/BE STUDIES:
Our experts can conduct, manage and monitor multicentre Clinical Trials in a wide range of therapeutic areas. We can monitor and audit BE studies in India and abroad. Our skills include:
- Medical Writing & Clinical Studies
- Clinical Trial Studies
- Analytical Solutions
- Bio availability / Bio equivalence Studies
- Clinical Trials studies
- Prepare Periodic Safety Update report (PSUR)
- Preclinical studies like Toxicity, Carcinogenicity, and Teratology & Reproduction toxicity
APC is associated with pharmaceutical facilities located in India and abroad with facilities having approvals from Various international agencies WHO cGMP, MHRA, TGA, MCC, ANVISA etc. We offer contract manufacturing for all dosage forms and can assist in the production of your APIs as well. Depending on needs of our valued clients, our services include purchasing raw materials, production, packaging and quality control.
Ready to fill pellets: We can enable sourcing of ready-to-fill pellets of wide range of products from WHO cGMP approved plants along with dossiers at very competitive prices.
Our service is aim to provide our clients with quality medicines at affordable prices.
We provide medical & drug safety services to pharmaceutical companies across the globe. Our expert team consisting of senior advisors, physicians & Pharmacovigilance professionals.
We offer end-to-end pharmacovigilance support for global pharmaceutical companies and clinical trials involving all therapeutic areas and to emerging pharmaceutical companies to develop and maintain their drug safety systems.
Providing high quality drug safety services to Pharmaceutical companies, Research organizations and health agencies.
Drug Safety Services
- End-to-end Case Processing (ICSRs) - case intake and triage, MedDRA coding, narrative writing and medical assessment
- Aggregate Reporting (PBRER/PSUR, PADER and DSUR)
- Preparation and submission of Periodic Safety Update Reports (PSURs) to Competent Authorities
- Writing of Risk Management Plans (RMP) / Risk Evaluation & Mitigation Strategies (REMS).
- Benefit-Risk assessment and communication to Regulatory Authorities and Healthcare Professionals
- Signal Detection & Management
- Preparation, review and approval of standard procedures for PV system
- Literature search
- Worldwide Literature screening through automated literature screening module
- Clinical Trial Safety Management
- Medical Information (including Call Centre Support)
- Regulatory Safety Assistance (pre & post-authorization)
- Standard Operating Procedures (SOPs), Working Instructions (WIs) & Guidance Assistance
- Audits & Inspection support’’
- Training & Consultancy
- Implementation of CAPAs
- Pharmacovigilance System Master File (PSMF) Preparation
- Turnkey Projects in Pharmacovigilance
APC is in product as well technology consulting for pharmaceutical, Vaccines, Biological, Diagnostics and Medical devices.
APC have associated with an US based organization and representing them in offering technology transfer for the following group of products:
Other Products such as:-
- Analgesics Antibiotics
- NSAIDS Gastrointestinal
- Respiratory Hormones
- Ophthalmology Gynecology
- Dermatology Neurology
- Vaccines Diabetes
- AIDS Papilloma, Lyophilized and powder
- Support in conceptualization of global business plan and strategy
- Setting up global infrastructure for marketing and distribution
- Enabling strategic tie-ups for technology transfer and global market access
- Portfolio optimization and augmentation
- Advisory for sourcing of products and technology of global repute.
IN & OUT LICENSING:
For out-licensing after definition and analysis of the products and countries, we search for partners in such countries with assortments and focus in line with the products to be out-licensed. In accordance with the clients wishes we assist during the negotiation and contractual phase, help during the registration process and look after the products during the pre-launch, launch and marketing periods.
For clients who wish to in-license products, we search for the needed products to optimize and complete their assortments in all fields of activity of our company. Like-wise and in accordance with the client’s needs we assist during all phases of product search, negotiation, registration and product launch and marketing.
In case special consulting services are requested, like strategy development, assistance in merger and acquisition processes, pre-due diligence activities, among others, we offer experience and flexibility to fulfill our clients’ needs.
All product (API, Ethical, OTC, Veterinary, Dietary and Cosmetic) offers for licensing are on behalf of the companies interested in their licensing. Information on available countries is on special request. Offers are only for countries with no opposing patent restrictions.
IMPORT & EXPORTS:
Registration of product for import and for export requires quality documentation with total quality management. Promptly responding to query should be mandatory to save time and create brand image globally.
We assist in following services related to import. We assist in getting permission of import registration as follows:
- Finished formulation
- API (Bulk drug)
- Medical devices
- Import NOC ( Form 10)
- Import Test License
Our export services clearly summarized as following points:
- Export Dossier
- B.E. Report
- Clinical Trail Report
- Shelf Life Extension for export
- PSUR ( PERIODIC SAFETY UPDATE REPORT)
- Embassy Attestation
- Export NOC
PHARMACEUTICAL TURN-KEY PROJECTS:
Afra Pharma Consultant has collaboration with an ISO 90001 certified worldwide Pharma consulting and engineering company with more than 1600 people at more than 20 locations worldwide and handles up-gradation projects to turn key projects in Pharmaceuticals, Biopharmaceuticals, Medical devices, vaccines and industrial biotech and API.
We offer professional services to clients’ specific requirements and take pride in providing current top quality STATE OF THE ART ENGINEERING.
We undertake comprehensive management of all project activities, right from conception through completion of construction and commissioning, including Continuous Monitoring, thereafter to achieve the projected savings in time and money to add value to our services for the benefit of our clients.
We also assist in the up gradation of plants in accordance with the latest industry standards.
We are proud to state that the Facilities we have successfully commissioned, in India and Abroad, have complied with the demanding standards and requirements of International companies like conforming to cGMP requirements and US FDA & UK MCA guidelines.
Afra Pharma Consultant assists clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing.
Our consultants will visit the your facility and carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMA, Saudi FDA, GCC etc.) after which we provide:
- An in-depth, impartial and professional assessment of their current state of compliance
- A detailed, prioritized action plan for the rectification of areas of non-compliance and vulnerability
- Staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them
- Sound, practical support and advice in the run-up to the real inspection.
Afra Pharma consultant has collaboration with leading trainers with 10-15 years industrial experiences and has conducted number of training sessions in Topics related to Regulatory, clinical research and cGMP.
We can conduct several training programs and interactive workshops on regulatory support periodically. The nature and course content is tailored to suit specific managerial levels in the organization.
APC also undertakes to develop and conduct courses with specific focus when specially requested by customers.
These courses can be conducted at either in-house or a private meeting room.
Mir Sadat Ali
H/201 Hillmist Harmony, NIBM Road, Pune 48, INDIA
Skype ID: afrapharma