Consulting, Validation and Compliance
| Anabase International | ||
At your service, Anabase offer a winning combination of scientific brains and technical brawn. |
Integral to our client’s team, we help guide the new product from concept to market and throughout its life cycle. |
We build, join and collaborate with research and development teams and international partners, assuring successful negotiations and interactions with the FDA and other regulatory authorities. |
| Anoto | ||
Anoto is the company behind the unique technology for digital pen and paper, which enables fast and reliable conversion of handwritten text into digital format. |
Digital pen and paper technology is ideally suited to form-based processes such as those commonly used within both health and social care. |
The digital pen and paper solution provides faster access to data and reduces costs in clinical trials. |
| Bio Nano Consulting | ||
Microcantilever system for assessment of drug binding. |
AFM imaging of membrane-bound proteins. |
Surface plasmon resonance detection of ligand binding. |
| BioTechLogic | ||
Step 1: Know the path. |
Step 2: Choose a guide. |
Step 3: Assemble the right team. |
Step 4: Finish the journey increase your efficiency and decrease the time to achieve global approval by calling Biotechlogic. |
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| Cerulean Associates | ||
Cerulean helps clients simplify and streamline their compliance and quality systems, allowing faster time to market, lower risk, and a stronger bottom line. |
Cerulean's SmarterCompliance™ newsletter and advisory program is relied upon by pharmaceutical, biotechnology and medical device executives around the world for timely, practical advice, insights and strategies. |
John Avellanet, Cerulean’s managing director and principal, has decades of experience balancing compliance and business priorities, and is a frequent speaker at industry events with FDA officials. |
Our clients range from executives in multinational pharmaceutical companies who want independent advice to lab directors and owners of small startups who need part-time regulatory and quality management help. |
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| Clinical Performance Partners | ||
CPP provides practical, easily implementable solutions to accelerate the completion of biopharmaceutical and medical device clinical trials. |
The ‘Leaky Pipe’ analysis developed by CPP over 15 years ago is used to validate enrollment potential, drive recruitment planning and diagnose recruitment and retention challenges. |
Our creative clinical research training programs are focused on skills enhancement using practical and proven techniques to ensure immediate application and results. |
| Croma | ||
Croma has the ambition to provide to our partners the best support in driving their products, quickly, safely and effectively into the Greek market. |
We believe in the strategic importance of regulatory affairs for the success of the pharmaceutical business, and in the demanding and constantly changing health environment at both European and local level. |
You can find in us the partner that in collaboration with you can break barriers, enabling the access of your products into the Greek market. |
| DBA | ||
David Begg Associates (DBA) is Europe’s largest provider of pharmaceutical training courses, including in-house pharmaceutical training courses and external pharmaceutical training courses. |
DBA’s Quality Leadership Program is a series of modular training services is based on the company’s successful QP training. |
Our pharmaceutical QP training courses are recognised by regulatory authorities within the UK and abroad. |
We also offer pharmaceutical auditing and consulting services. |
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| Del Corno & Associati | ||
Del Corno & Associati provides regulatory consultancy services to the pharmaceutical industry. |
Del Corno & Associati helps companies develop and obtain the appropriate authorizations to market medicinal products, medical devices and food supplements. |
Del Corno & Associati supports regulatory filings, pharmacovigilance and CMC compliance. |
| FCA | ||
Our consultants provide comprehensive quality, regulatory and compliance strategies to the pharmaceutical, biotech and medical device industries. |
Training is an integral part of any FDA-regulated environment and our consultants provide extensive training in applying meaningful strategies for compliance with 21 CFR Parts 210 and 211. |
Investigation is mandated by good manufacturing practice (GMP) regulations (21CFR211) and quality systems regulations (21CFR820). |
An effective quality system / cGMP management system must evaluate various elements of a given process and implement monitoring strategies for continuous improvement. |
Marie Florestal is the founder of Florestal Consulting & Associates (FCA), a full-service GMP and quality systems consultancy. |
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| H M Pharma | ||
With its integrated advisory services tailored to bio-pharmaceutical companies, HM Pharma Consultancy provides new perspectives in drug development and diagnostic development. |
HM Pharma Consultancy utilizes all available information sources – scientific papers, patents, news releases, and others - to build a comprehensive picture of the landscape defining therapeutic areas. |
We assist in strategic patenting – which includes advice on entire patent portfolios, and helping companies obtain and defend intellectual property. |
HM Pharma Consultancy burrows deep to help life science companies develop their business, market analysis, intellectual property services, scientific expertise, and excellent contacts to specialized CROs mesh together. |
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| Insymbiosis | ||
From first discussions with a client through to the achievement of project deliverables, InSymbiosis' proven project management process ensures that projects are executed and delivered on time, on budget and to the highest scientific standards. |
InSymbiosis’ drug development consulting service covers the complete discovery process from validation of a drug target through to optimization of a lead compound. |
At InSymbiosis, our regulatory consulting service also encompasses completion of the chemistry, manufacturing and control (CMC) and non-clinical sections of the submissions and interactions with the regulatory authorities. |
InSymbiosis is able to provide GLP compliant toxicology and safety pharmacology services, including the preclinical program management and monitoring of these important studies. |
Working in symbiosis towards your therapeutic goals, our team of experts will accelerate your progress and compliment your core strengths. |
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| International Regulatory Business Consultants | ||
International Regulatory Business Consultants are recognized health care manufacturing industry experts, with a blend of technical and business education and expertise in the global healthcare industry. |
We have a strong suit of organizing groups and establishing and implementing systems which produce results, as evidenced by successful company integrations from merger / acquisition activities and product approvals. |
Integrating the manufacturing and quality operations in a multinational organization to ensure uniform and consistent quality standards and systems. |
| IWA Consulting | ||
A quality check of the printed submission; eCTD makes life easier. |
Ready to be packed and shipped: for eCTDs this process is easier and cheaper, and ecological too. |
IWA Consulting is an internationally recognised health care regulatory consultancy offering expertise in European registration procedures, new drug development, regulatory strategies, scientific advice, CTA, eIND, Investigator’s Brochure (IB), orphan drug applications and SME applications. |
| Lifescience Dynamics | ||
Our team of experts will collaborate with you to ensure the scope of your project is clear and realistic. |
LSD specialises in ‘lifecycle management’ from new product development to loss of patent protection. |
Our experienced practitioners and industry strategists employ cutting-edge business thinking based on years of experience within the pharmaceutical industry. |
| Panacea Clinical Research | ||
Panacea has developed strong synergies with a range of companies to provide the client with a full spectrum of services. |
Panacea has supported IND and IDE studies in a multitude of therapeutic arenas, ranging from cardiovascular and ophthalmology to psychiatry and orthopaedics. |
Panacea Clinical Research preserves the integrity of clinical research by assuring that ethical obligations and regulatory requirements central to our industry are met. |
| Solutions 4 Science | ||
S4S can map warehouses upto 250,000ft² |
Ultra cold and cryogenic work is commonplace for S4S. |
Many national cold chain fleets already supported. |
Load and bottle studies are integral to understanding your cold chain. |
All S4S software is validated to demonstrate it is ‘fit for purpose.’ |
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| Turio | ||
Turio offers a comprehensive range of scientific, technical, regulatory and management services to pharmaceutical, biotech and private investing companies. |
The highly qualified team includes ex-FDA and MHRA inspectors and is assisted by a network of professionals which cover all areas of pharmaceutical and biotechnology expertise. |
Turio have sucessfully completed projects in pre-clinical development to IND submission of a lead candidate in oncology. |
| Validapro BioSciences | ||
Validapro BioSciences is a unique integrated services center for the life sciences industries. |
Validapro BioSciences is a consulting firm entirely dedicated to fulfilling regulatory compliance needs in the pharmaceutical, biotechnological and medical devices industries. |
Validapro BioSciences is able to offer a turnkey approach where engineering, project management, training, preparation of procedures, bioassays developments and validation integrate perfectly. |
ImmunoTox Labs division is fully GLP compliant facility with ultra modern labs and state-of-the-art instrumentation. |
ImmunoTox Labs analytical capabilities include: analytical, bioassays and in-vitro and in-viro. |
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