| Innovative_Bio_Biz Offers patented technologies for licensing. Includes portfolio. Located in Hong Kong. |
| Integra_BioScience_Consulting,_Inc_ Scientific, management and financial consultants to the biotechnology and biopharmaceutical industries. |
| Joklik_and_Associates,_LLC Specialty in the design of training solutions, organizational strategies and work processes in science and compliance industries from Severna Park, Maryland. |
| Madison_Keats Investment banking services for select clientele from the life sciences industry. Specializing in strategic planning, licensing, M&A, private placement, and business valuation services. |
| MG_Pappas_and_Company_Biotechnology_Consultants Specialists in grantsmanship and liaisons between biotechnology and pharmaceutical firms and federal agencies. Includes information on experience, services, books and clients. |
| Mulligan_BioCapital_AG Flash presentation from investment consultants offering a portfolio, strategy, implementation guidelines, and news. Based in Hamburg, Germany. |
| Pacific_Biodevelopment,_LLC Pacific BioDevelopment, LLC (PBD) provides consulting services to the pharmaceutical and biotechnology industries. |
| Pharmaceutical_Medicine_Consultants Provides information, links, and resources on pharmaceutical medicine, including qualified consultants, continuing medical education, and clinical investigator training programs. |
| Pharmaceutical_Regulatory_Services Provides regulatory support of various aspects of drug development, including clinical trials, marketed products, generics, OTC products, medical devices, as well as regulatory activities related to m |
| PharmaVentures_Ltd A healthcare consultancy assisting pharmaceutical and biotechnology companies in market and technology evaluation, product portfolio assessment and strategic business development issues. |
| PharmSupport-Peer_Productions,_Inc_ Consultation and training services to the pharmaceutical and biotechnology industries, with expertise in small-scale consulting, writing, and training projects, as well as large-scale, full-service In |
| Seraphim_Life_Sciences_Consulting_LLC_ Offers regulatory, operations, due diligence, advisory and corporate development services to drug, biopharmaceutical and medical device companies and investors. European contacts, with headquarters in |
| Swift_Water_Group Management consultants to the pharmaceutical industry. |
| T_and_D_Technology Specialty in biosensors, chemical sensors and other analytical devices using of enzymes or whole cells, and polymer synthesis. Includes brokerage, technology, client examples, consultancy areas, and d |
| Vision_Biotechnology_Consulting Specialists in drug, device, and diagnostic product development, clinical trials, and manufacturing. |
| Wardell_Associates_International_LLC Consultants to the pharmaceutical and biotech industries on drug development and business strategy, product approval, and market support. |
| ASSOPIUMA Italy. Trade organisation for processors of feather and down, and feather and down filled products, dedicated to promotion and quality certification. Extensive technical information. List of member co |
| CFDIA__China_Feather_&_Down_Industrial_Association Trade organization for Chinese processors of feather and down, and manufacturers of feather and down filled textile products. Business news and trade opportunities. List in events. English and Chinese |
| Down_Association_of_Canada Non-profit organization, devoted to maintaining quality standards for down and feather products sold in Canada. Consumer information about the properties, qualities and care for down and feathers. Lis |
| European_Down_&_Feather_Association_(EDFA) Germany. International membership organization for associations of the bed-feather industry and trade, manufacturers, processors and dealers in raw feathers and down, and testing institutions special |
| IDFL__International_Down_and_Feather_Laboratory USA. Independent laboratory for testing, consulting, training, and research in the down and feather industry worldwide. Extensive library of technical and newsletter articles. Links to related sites. |
| America\'s_Car-Mart Automotive retailer with over 60 dealerships in multiple states. (Nasdaq: CRMT). |
| Auto_Dealer_News_-_Topix_net News on the auto retail industry continually updated from thousands of sources around the net. |
| Brake_Masters Auto repair and brake parts chain located in the Southwest United States. Include store locator and franchise information. |
| Car-X_Muffler_and_Brake United States nationwide shops service brakes, mufflers, exhaust systems, oil and lube, alignment and tires, includes store locator and coupons. |
| Central_Tyre United Kingdom tires and auto parts store chain. Includes branch locator and contacts. |
| Hometown_Auto_Retailers,_Inc_ Sells new and used vehicles and replacement parts, provides repair and maintenance services, and financing, insurance and service contract through franchised dealers. (Nasdaq: HCAR). |
| Jiffy_Lube Chain of fast lube and oil change centers in the United States. Includes locations and contacts. |
| Midas Auto maintenance and repair services including brakes, exhaust, and suspension. Locations across the United States and Canada. |
| Midas,_Inc_ Parent company for Midas International Corporation and other Midas operating units. Provides retail automotive services through franchised and company-owned locations. (NYSE:MDS) |
| Monro_Muffler_Brake,_Inc_ Provides automotive undercar repair services, including muffler and exhaust system repairs, brakes, steering, drive train and other products and services for domestic and foreign cars, light trucks an |
| National_Automobile_Dealers_Association Resource for auto retail professionals. Provides industry trends, education and training, and career information. |
| Oil_Can_Henry\'s Lube and oil change chain, with locations in 5 western states and in Minnesota. Services offered, locations, business philosophy, and franchising information. |
| Pep_Boys Operates stores in 36 states and Puerto Rico, selling brand-name and private-label automotive parts and offering on-site service facilities. (NYSE:PBY). |
| PROCARE_Automotive_Service_Centers Automotive repair and maintenance services across the United States. Includes locator and maintenance tips. |
| Rush_Enterprises,_Inc_ Operates regional network of truck centers which offer integrated trucking needs for customers including retail sales of Peterbilt trucks and parts, service and body shop facilities and truck leasing |
| Tires_Plus Operates auto service shops across the United States. Includes online coupons, description of services and a listing of locations. |
| Australian_Ethical_Investment Manages ethical investment unit trusts, with a goal of balancing social responsibility with financial returns. Australia |
| Boston_Common_Asset_Management Portfolio management with customized social screening and shareholder advocacy. Domestic and international products. United States. |
| Brody_-_Weiser_-_Burns Consulting firm assisting foundations and other institutions in structuring and managing program-related and social investments. United States. |
(301) 260-2200 dhai@msn.com
Don Hill & Associates, Inc., founded in 1990, provides consulting services to the biotechnology, biologics, and pharmaceutical
industry.
The company is comprised of former FDA officials and pharmaceutical
industry personnel, all with hands-on experience in interpreting and applying cGMPs
and regulatory requirements. Our clients include major multi-national pharmaceutical companies, start up operations and clinical manufacturing, virtual companies and contract
manufacturing organizations (CMO).
Don Hill and his select cadre of qualified associates bring many years of
FDA regulatory and quality assurance experience to help
you achieve your objectives and needs for biotechnology products,
vaccines, cellular and gene therapy and more recently in traditional small
molecule drugs. This experience includes:
• Recognized worldwide for expertise in evaluation of manufacturing facility design,
validation and process operations;
• Performing cGMP audits of API, clinical manufacturing and fill/finish facilities, manufacturing
operations, quality systems and documentation;
• Preparing clients for pre-approval, biennial and "for cause" cGMP inspections;
• Providing technical assistance in the development and manufacture of monoclonal antibodies, vaccines,
chemical synthesis and polymer products;
• Assessment of the potential regulatory risks inherent in the manufacturing process, the scientific
rationale for the development program and the strength of the validation approach.
Providing alternatives for mitigating risk;
• Design and implementation of Quality systems for the development and manufacture
of biologics and pharmaceuticals;
• Substantial experience in the development and implementation of
successful regulatory CMC strategies to ensure IND and CTA acceptance for conduct of early phase
through late phase clinical trials and product registration;
• Review and/or prepare CMC filings for regulatory submissions such as IND, CTA, BLA, NDA,
MAA Master Files;
• Review and/or prepare Quality agreements for contract manufacture;
• Review and/or prepare Briefing Documents by establishing agendas and content for meetings with
regulators;
• Write/edit/review responses to regulatory agency inspection observations and regulatory
questions or requests;
• Providing training tailored to your company needs on compliance to regulatory agency cGMPs,
regulations, facility requirements, quality systems, validation of manufacturing
facilities, equipment cleaning and environmental monitoring.
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