Afra presentation (profile)
- 2. Presented By Mir Sadat Ali www.afrapharmaconsult.org
- 3. COMPANY DESCRIPTION Afra Pharma Consultant (APC) is a private limited company based in Pune, India, established in the year 2011, and is the leading provider of quality resource for the regulation of pharmaceutical products including those deemed as consumer Health and OTC. The services are designed to meet all of the latest regulations, helping clients to meet all of the stringent requirements of the pharmaceutical world. Afra Pharma Consultants has a satisfied network of clients, situated throughout the Europe, Asian countries, North Africa, GCC, Saudi Arabia and India. Afra Pharma Consultant 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. www.afrapharmaconsult.org
- 4. EXPANDING CONSULTANCY BEYOUND EXCELLENCE www.afrapharmaconsult.org
- 5. Our Goal: is to enable you to achieve your goal and to be the first choice of our clients in all their needs and services we offer. www.afrapharmaconsult.org
- 6. Our Mission: is to Excel Exceed customer Expectations by delivering the commitments we make. www.afrapharmaconsult.org
- 7. Our Vision: being recognized as successful provider of superior quality and cost effective services to the Pharmaceutical Industry worldwide. www.afrapharmaconsult.org
- 8. OUR SERVICES The services are designed to meet all of the latest regulations, helping clients to meet all of the stringent requirements of the pharmaceutical world: REGULATORY CLINICAL RESEARCH PHARMACEUTICAL ENGINEERING TRAINING PIL PROJECT MANAGEMENT AUDITS AND INSPECTIONS STRATEGIC PLANNING www.afrapharmaconsult.org
- 9. OUR EXPERTISE Several companies die due to inability to deal with changing regulatory requirements in a specific region. Our objective is to provide customize solution to any such problems through the highly talented and experienced group of consultants from Middle East. Middle East and North Africa is our strength and we can cater all your requirements in this region such as: Identifying potential collaborators for joint venture projects in the GCC. Identifying potential acquisition/joint venture/ partnerships in the GCC Market place. Mock cGMP Audit Technology, Acquisition and Transfer. www.afrapharmaconsult.org
- 10. OUR EXPERTISE Identification and evaluation of Contract Manufacturing Services. Sourcing of Pharmaceutical equipment and raw materials. Designing state-of the art manufacturing facilities Revamping and upgrading existing manufacturing plants Helping in identifying & refining Strategic Business Direction. Production Rationalization Preparing dossiers and drug registration with the Saudi FDA, GCC. Training for cGMP and all regulatory related topics. www.afrapharmaconsult.org
- 11. REGULATORY 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 is total confidentiality, time bound submissions and providing regulatory support till the product is registered and marketed. www.afrapharmaconsult.org
- 12. REGULATORY Dossier compilation as per: ASEANCommon Technical Dossier (ACTD) Guidelines. South Africa (MCC-MRF-1) Guidelines Brazil ANVISA Guidelines. Dossiers compilation for submissions in: Asia Africa Central America South America North America www.afrapharmaconsult.org
- 13. REGULATORY Dossier compilation in Common Technical Dossier (CTD) format for Commonwealth of Independent States (CIS) Guidelines. South East / West Europe Guidelines. Drug master file (DMF) compilation for open and closed parts Prepare Summary of product (SPC), Pack Insert, Product rationale. Expert Reports Quality, Pre-clinical, Clinical Nonclinical Study Reports (Module 4) Clinical Study Reports (Module 5) Dossier conversion (from one country to another) www.afrapharmaconsult.org
- 14. PRE AUDIT 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 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. www.afrapharmaconsult.org
- 15. CLINICAL RESEARCH ORGANIZATION Afra Pharma consultant offer to conduct, manage and monitor multicentre Clinical Trials in a wide range of therapeutic areas and monitor BE studies in India and abroad. We have a special interest in Independent Clinical Trial Monitoring Work in India and abroad for sponsors from India and abroad. Medical Writing & Clinical Studies. Bioavailability. Bioequivalence. Clinical Trial Studies. Analytical Solutions Reports on Bioavailability / Bioequivalance Studies, Clinical Trials studies Prepare Periodic Safety Update report (PSUR). Preclinical studies like Toxicity, Carcinogenicity, and Teratology & Reproduction toxicity. www.afrapharmaconsult.org
- 16. PHARMACEUTICAL ENGINEERING Afra Pharma Consultant has collaboration with an ISO 90001 certified worldwide Pharmaconsulting 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. www.afrapharmaconsult.org
- 17. TRAINING Afra Pharma consultant has collaboration with leading trainers with 10-15 years industrial experiences and have 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. www.afrapharmaconsult.org
- 18. WHY APC Experienced, Professional, Focused practice and easy to work with. We specialize in preparing and handling regulatory submissions for Saudi FDA and GCC. For mock Audit as per MHRA, SFDA and GCC. Reach out to Global Market. To have timely and faster dossier preparations and submissions. For one stop requirements for all your regulatory needs. Offer concept to commissioning (turn key projects) of pharmaceutical and CRO facilities. Wide network of consultants across India, U.K, U.S.A, Middle East to South Asian Countries. www.afrapharmaconsult.org
- 19. H/201 Hillmist Harmony,NIBM Road, Pune 48. Email: info@afrapharmaconsultant.org www.afrapharmaconsult.org