Section heading Strapline sub-heading Smart every time NextPharma stands out as your pharmaceutical development and manufacturing partner with fast, flexible and tailored solutions for markets worldwide
Evolving as a global CDMO Being a preferred outsourcing partner means being ready to support the challenges our customers face today and tomorrow. Value driven in our approach Throughout 2013, we have focused on realigning and enhancing our core business, putting the right people in place to drive our progress and demonstrating the qualities our customers tell us they value most: Technical expertise and excellent quality Flexibility and responsiveness Commercially competitive Reliability Speed in execution Communication - always well informed Experts in solids, semi-solids and (non-sterile) liquids. Specialist containment and unrivalled know-how for: Hormones Cephalosporins Penicillins Controlled substances 7 of top 10 pharma companies are partners 4bn tablet capacity 500m finished packs produced Double-digit growth 1,000 employees, 25% working in quality & regulatory 65 scientists handling 150 development projects a year 100+ audits each year 10,000+ batch releases NextPharma s core values summarise our smart every time approach: Service Passion Speed One global team, with our customer at the centre of everything we do. Proud of our skills and technologies. Passionate about how we apply them. Always aware that our agility and flexibility are a competitive advantage for our customers. www.nextpharma.com 2
Smart every time The people at NextPharma provide a unique combination of scientific, technological and market knowledge. High calibre expertise Our objective advice and expert guidance will make the difference in getting to the next trial phase or launching faster and more efficiently. At NextPharma, we have established centres of excellence across all of our locations, each operating globally with common processes to ensure that best practice in project management and scientific knowledge is applied consistently to meet your deadlines. Speak to one of our experts to hear first hand how we can help your products succeed or ask to see some of our customer success stories. Whether as a start up, virtual pharma or one of our world leading multinational customers, we take each project and apply an innovative and customised approach, to match your specific requirements and standards. Competitive and responsive across a range of services: Pre-clinical development Formulation development and selection Analytical method development Stabililty testing Clinical development Phase I - III clinical trials Bio-equivalence studies Regulatory development Commercial Supply Validation batches Technology transfer Launch and supply info@nextpharma.com 3
Pharmaceutical Development At NextPharma we have the scientific, regulatory, and product development expertise to support a wide range of projects. You can rely on our drive, transparency and innovation for any type of challenge. Formulation and Process Development Our personalised project management will nurture your product from development through to scale-up and commercial manufacturing. As early in your project as possible, our goal is to establish a process that sets you up for commercial success. Formulation development Formulation plan tailored to each project/dosage form Analytics testing against required product profile Formulation optimisation Finalisation of formulation composition and product specification Forced degradation studies and supportive stability Analytical method development and early phase validation Scale-up and process delivery Process development Analytical methods late phase validation Manufacture of registration batches ICH stability NextPharma also provides scientific and regulatory advice related to the CMC section of product filings. www.nextpharma.com 4
Clinical Trials Services From our dedicated centre, we reliably deliver flexible, tailor-made solutions to customers worldwide. Technical know-how to quickly and precisely meet your small and large scale drug and placebo manufacturing needs A dynamic range of equipment and flexible capacity to meet your de-blistering, blinding and over-encapsulation needs Our team of experts will work with you to overcome any project challenges and will provide the most intelligent packaging solution Cost-effective comparator products and our global warehousing and distribution network can ensure fast delivery around the world All clinical trial materials are produced in our GMP-compliant facility before our in-house QPs release products for clinical study. Analytical Services Analytical testing is carried out at the state-of-the-art NextPharma laboratories. Rapid testing of drug products to registration stability and commercial release Outstanding technical support and problem-solving experience Dedicated microbiology laboratory with over 40 years experience Responsive, tailor-made solutions from our highly skilled CTS team. info@nextpharma.com 5
Commercial Manufacturing Our manufacturing centres of excellence provide our customers with reliable product supply in facilities that include European, US FDA and ANVISA approvals. Technology transfer Always driven by your deadlines and flexible in our approach, you can have confidence that transferring your finished product to our facilities will be managed seamlessly. From launch to commercial supply With an agile approach and wealth of experience, we ensure our customers obtain the right value through our collaboration. We excel across a range of dosage forms, as well as specialist technologies such as modified release (including pellet and bi-layer tablets). We also have a strong track-record with drugs requiring containment areas such as hormones, penicillins, cephalosporins and controlled substances. Flexible capacity from our integrated network of world-class GMP facilities. NextPharma has a strong track-record across a range of dosage forms: Solids Semi-solids Liquids Tablets Capsules Granules Powders Effervescents Pellets Coating Suppositories Ointments Gels Creams Solutions Drops Sprays Suspensions A broad range of highly tailored or large-scale primary and secondary packaging solutions for each form Blister packs Sachets Tubes Stick packs Glass or plastic bottles Pump sprays Ampoules www.nextpharma.com 6
Centres of Excellence Our roots go back more than 50 years. From our 5 development and 6 manufacturing centres of excellence, we now serve over 150 customers across 6 continents. Surrey, UK Head office Limay, France Liquids, suppositories East Coast, USA Sales & Service, North America Berlin, Germany Penicillins Bielefeld, Germany Modified release, Analytical services Göttingen 1, Germany Solids, Clinical Trials Services Göttingen 2, Germany Cephalosporins Waltrop, Germany Hormone solids & semi-solids Specialists in: Hormones Penicillins and Cephalosporins Modified release Narcotics Paediatric Mini tablets Flavoured solutions Solutions Pellets Semi-solid production, Waltrop info@nextpharma.com 7
PRIDE CHOICE QUALITY PASSION UNCOMPROMISING EXCELLENCE AWARE AGILITY EXPERT GLOBAL SERVICE CUSTOMER FOCUS ADVANTAGE SPEED FLEXIBILITY NextPharma Tel +44 (0) 1483 479 120 info@nextpharma.com www.nextpharma.com Brochure title nextpharma 8 Connaught House, Portsmouth Road, Send, Surrey GU23 7JY, United Kingdom