C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
C-Tech Analytical Solutions
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A winning strategy is essential to reach or accomplish goals in pharmaceutical industry. However, maintaining the excellence of Strategic Drug Development Services is a necessary stipulation for the Strategic evolution for Pharma companies. The technologies leading to Pharmaceutical regulatory strategy and Pharmaceutical strategic developments are at the limits of human knowledge. The huge size of the companies, organizations and the complexities of their technologies and processes present many challenges. On the other hand, strategy development and distribution system is highly costly to implement. The effective Pharma strategies can help to generate business exposure, relationship building, and market research. Thus, they are important initiatives to boom overall business in the long term.


Adopting industry best practice requires three critical skills

Every life science company is eager to find and absorb industry best practices and for good reason In a business environment that is changing quickly no firm can afford to be left behind and relying on internal experience and lessons is too slow It is essential to imitate as well as to innovate


Can advanced dual-chamber solutions help?

Latest figures show that China is the second pharmaceutical market in the world after the United States with an overall value amounting to about billion dollars in


Key trends in 2021

The first Biosimilar was approved in the year in the European Union and since then there have been more than biosimilar drugs that have been approved Not surprisingly there has been phenomenal growth in the biosimilars market an Assocham report states that the global biosimilars market is estimated to reach US billion by while the Indian biosimi...

Current Trends in Regulatory Outsourcing Models

Pharmaceutical companies of all sizes are increasingly outsourcing elements of the development process including regulatory affairs This helps them to access specific technical regulatory or geographic expertise to flexibly augment staffing levels without adding to headcount and to deliver key operational outputs enabling internal staff to focus on...

China’s New PRC Biosecurity Law

Key implications for international players

Against the background of the COVID global pandemic China fasttracked and passed last year its first national biosecurity law Biosecurity Law The law which took effect on April of this year adds another key component to Chinas overall national security

An Overview of Clinical Overview

A Clinical Overview is an integrated document intended to provide critical analysis of Pharmacology Efficacy and Safety of the pharmaceutical agent in humans It is one of the important documents of Module of the Common Technical Document CTD ie Module which refers to the data provided in the comprehensive clinical summary the individual clinical...


If you’re not thinking ecosystems, you’re not thinking

To an ecologist an ecosystem is a biological community of interacting organisms and their physical environment This concept helps us to see that ecosystems in the life science industry are not simply subparts or the market or the industry They have wide boundaries and those boundaries blur and overlap with other ecosystems

Brexit and Pharmacovigilance

Where may pharmaceutical companies go?

What may happen to sick people should medicinal products suddenly not be available owing to Brexit Some million patient packs go to the European Union EU from the United Kingdom UK every month with a further million patient packs moving from the EU to the UK

Biomedical Market Leaders

Learning to thrive

If you have worked in the biomedical industry for more than a couple of years you will have noticed one of its most characteristic features change Pharma medtech and related businesses operate in a complex environment of two halves the sociological and the technological Our sociological environment including demography epidemiology and politics is...


A US perspective

When a pharmaceutical company first develops a new drug or any device to be used for the treatment of a disease it is initially marketed under a brand name by which clinicians can recommend or prescribe the drug or any device for use by patients

Understanding Bio-summary Tables for ANDA Submissions

Biosummary tables also known as Division of Bioequivalence DBE Tables are one of the main prerequisites for Module submitted to the United States Food and Drug Administration US FDA as a part of the eCTD dossier

Innovation in pharmacovigilance

Where does Israel stand and ISOP ISRAEL role?

The Israeli pharmacovigilance system was founded recently All over the world pharmacovigilance regulations have evolved mainly from lessons learned as a reaction to safety issues that became public health issues

Challenges and Solutions in HCP ELISA Development

The importance of reliable Host Cell Protein (HCP) monitoring during manufacturing of biopharmaceutical drugs

Biopharmaceutical drugs make up a large portion of global pharma sales with of the top global drug blockbusters in being recombinant biopharmaceuticals Drug development is separable into five phases


Solving the toughest water and process challenges

Im originally from Belgium and I studied to be a chemical engineer with a specialisation in biochemistry and biotechnology When I started out it was my goal to get into the biochemistry or biotechnology industry as a plant director but when I graduated from university my first job was teaching chemistry biology and math Teaching was a very good exp...


EU Pharma's strategic imperative

Vietnam is the European Unions EU second largest trading partner in ASEAN and close to per cent of EU exports to Vietnam are pharma products For various midtosmall sized EU pharma players Vietnam has remained an alliance or a distributor led market With increase in demand positive economic prospects increase in per capita healthcare spending and t...

Health Canada New Validation Rules (Version 5.0)

For eCTD and non-eCTD Submissions

Health Canada is the Agency responsible for the wellbeing of the Canadians by ensuring highquality health services and minimising the health risks Regulatory submissions for Health Canada can be done in both electronic Common Technical Document eCTD and nonelectronic Common Technical Document noneCTD formats

The Swiss Chees Strategy

By copying the aviation industry, you can make sure your marketing strategy will fly

As you look at your newlywritten marketing plan you might want to reflect for a moment how much it resembles an airliner it took a lot of effort to build you want to be as sure as you can be that it will fly and not crash but once it takes off it is difficult to repair The biggest difference between a marketing strategy and an airliner is that whil...

Pharma Trade Terms in Asia-Pacific

Time for a reset!

Trade terms represent a growing investment and cost item for most Pharma companies globally In AsiaPacific APAC price pressures from limited healthcare budgets and preference to generics under universal coverage have led to additional challenges widening gross to net investments made by Pharma In our surveys from last year per cent of Pharma execu...

Nanotechnology to Combat Covid-19

Rapid viral outbreaks have caused great inconvenience to mankind especially since the last decade The latest addition to the list is severe acute respiratoryrelated coronavirus SARSCoV or more commonly COVID Figure As of September this virus has a spread over countries around the world affected people and caused deaths Nanotechnology and nan...


Strategic planning processes must adapt to the new normal of social distancing

Right now all over the world crossfunctional teams in pharma biotech medtech and other life science companies are working on their strategic plans Large or small companies usually follow this annual ritual

A Decade of Reinforcing Business Integrity

Making Asia-Pacific better prepared for COVID-19

The AsiaPacific APAC region is no stranger to confronting and defeating disease outbreaks From SARS and Avian influenza to MERS and HN the regions economies have demonstrated remarkable resilience and with each new occurrence found themselves better prepared to confront the challenge

Crucial Decision-making in Drug Development for COVID-19

Modelling and simulation guides

Modelling and simulation has been growing rapidly in impact and is now actively used by biopharmaceutical companies worldwide for drug development and regulatory agencies for review and approval



There is a widespread panic around the world about COVID caused by the novel Coronavirus In late December China health Officials reported an outbreak of pneumonia of unknown origin in Wuhan Hubei province The World Health Organisation WHO originally called this disease Novel Coronavirusinfected Pneumonia NCIP and this novel coronavirus was provisi...



China and India are the leading players in bulk drugs and manufacture more than per cent of global bulk drug China is the largest bulk drug supplier in world and India is second As reported by ministry of commerce India exported drugs formulation and biologicals of billion USD in which increased to billion USD in increase



Viral outbreaks are not new to the world Before COVID we had other outbreaks such as Ebola in Swine Flu HN in and Severe Acute Respiratory Syndrome SARS outbreak in But the COVID outbreak became a pandemic and broke the record of all viral outbreak in past years forcing the World Health Organization WHO to declare health emergency globally

Natural Intelligence

True AI is a distant promise for marketers

Despite the hype the routine use of AI in marketing in the life sciences is a long way away

Self-leadership in Developing Mental Capital

An essential approach for effective multicultural and multidimensional leadership

Leading in todays culturally diverse workplaces with multidimensional processes and stakeholders requires individuals to adapt to new environments learn new skills and manage a range of stresses and strains between the interface of professional and personal life


The Pharmaceutical industry has been growing in parallel to human evolution

Promoting Regulatory Collaboration and Convergence in Asia

In the WHO published an article in its Drug Information Bulletin titled Collaboration not competition developing new reliance models The articles authors argued that modern medicines manufacture and distribution were becoming more and more globalized and that as a consequence the manufacturing processes and supply chains of pharmaceutical products...



When researching my latest book life sciences CEOs told me that the most important and fulfilling part of their job was developing the people who worked for them


Let me put up the disclaimers up front I have been an employee in the Indian pharma industry and currently run a consultancy business where several leading pharma companies are our clients

Reshaping Pharmacovigilance

ISOP ISRAEL experiencecan

Pharmacovigilance has undergone tremendous changes since the Vioxx story in which triggered the risk management approach worldwide



Personalised medicine is going to change the shape of the pharmaceutical market in the years to come


As per ICH QA guidelines impurity in a drug substance is any component of the drug substance that is not the chemical entity defined as the drug substance and as per ICH QB guidelines impurity in any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product

Is Blockchain the Right Technology for the Pharma Supply Chain?

A marriage between blockchain and the pharma supply chain is not preordained

Designing Sustainable High Performance in Business-to-Business Collaborations

With a cognitive systems engineering approach

In todays fast paced world of biopharmaceutical innovation no one individual or single organisation can really work alone

Today’s Line Managers

More of mentors and facilitators and much less of bosses

Gone are the days when line managers used to visit once in a while for joint working with their team members for a few days meet some important doctors and before leaving issue stern instructions to the team members that they should meet their targets without fail failing which they may not be in the team for long


Swiss government chooses the wrong medicine with reference price system for drugs

Since autumn the first package of costcutting measures in Switzerlands healthcare system is being reviewed One of the measures is the socalled reference price system for pharmaceutical whose patents have expired The Government Health Department has given two models to the consultation


Imagine you could genetically engineer your medical marketing team. You can

Allow yourself a moment to dream Imagine that you could give your medical marketing team superpowers What would they be Being invisible would allow your marketers to watch competitors as they work Being able to read the minds of key opinion leaders would make your medical affairs team incredibly insightful Time travelling market access teams could...


Use Cases in the Pharmaceutical Industry

What is Blockchain A Blockchain is a global distributed ledger or database running on millions of devices and open to anyone where information and particularly anything of value can be moved and stored securely and privately Tapscott et al On the Blockchain trust and integrity amongst strangers is established not by intermediaries but through mass...


Seventy years ago average life expectancy globally was today it is Seventy years ago million people worldwide were infected with smallpox today none The disease is eradicated Thanks to initiatives such as Gavi the Vaccine Alliance more than per cent of children now get early immunisation


In ethically promoting Pharma business field force are the resources who generate prescriptions for the products being promoted thus bring in revenue therefore the figures at the top of the line always depend upon their contribution However not all members of the field force are consistently hitting the numbers If we enable most of the field force...



The increasing cost of research in the west the ongoing tightening of regulations and pricing policies and major funding cuts for biomedical research have led to an increased interest in the outsourcing of clinical trials Not only is the APAC pharma market growing faster than the rest of the world it has a large treatment nave population and has sh...

Why Quality Standards of Drugs has to be the Primary Focus Area for Pharmaceutical Industry

Perhaps not as rampantly in the developed countries but definitely in the developing countries and especially in India access to medicines comes first even earlier than the access to healthcare facilities or doctors This essentially means that come illness most likely one would swallow a pill first and then visit a doctor if at all deemed neces...


How China is investing in its pharmaceutical market

Recent legislation has forced the Chinese regulatory environment to evolve establishing a friendlier environment for pharmaceutical development These changes may opendoors for pharmaceutical companies but they also create the need to adapt to the fastchanging regulatory requirements and the uncertainty that comes with legislative change The...

Advancing Production Capabilities to Boost China’s Pharmaceutical Market

The path forward is paved with Industry 4.0 and brand security solutions alongside regulatory change and new infrastructure

China is the second largest pharmaceutical market in the world according to a Top Markets Report on the countrys pharmaceutical industry by the International Trade Administration The same report also forecast the country to grow from US billion in to US billion by However despite the markets sheer size several hurdles line the path in moving

Integrated Drug Development Strategy

The nexus to value-based pricing

The burgeoning costs of healthcare globally are not sustainable The Tufts Center for the Study of Drug Development reports that it costs on average US million and years to develop and obtain regulatory approval for a new drug Driving up drug prices is the fact that only per cent of drug candidates entering clinical trials result in an approved dr...

Statin Drug Interactions and Related Adverse Reactions

Statins are a wellestablished class of drugs for the treatment of hypercholesterolemia with a proven longterm safety profile Statins have been shown to reduce the risk of cardiovascular morbidity and mortality in patients with or at risk for coronary heart disease Catapano et al Statin use is expanding and approximately per cent of the world popu...

The Evolution of Brand Strategy

As the pharmaceutical market transforms, so does the meaning of brand strategy

Imagine being a fly on the wall when I conduct one of my research interviews in a pharmaceutical medtech or diagnostic company Observe what happens when I ask one of my carefully worded questions Please describe your brand strategy Since I research across many countries and disease areas the answers vary in detail But witness enough interviews and...

The Importance of Post-Hire Screening in the Pharmaceutical Industry

Preemployment background checks are generally wellaccepted as part of the hiring process in highlyregulated sectors such as the pharmaceutical industry With patents and other valuable intellectual propertyoften worth millionsat risk the potential of sabotage from activist groups theft from industry rivals potential insider threats and not to forget...

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