Pharmaceutical Consulting

Both the Pharmaceutical and BioTech industries show great promise as they deal with essential areas of public life such as health, quality of life, and lifestyle.

The innovative pharmaceutical industry includes companies engaged in developing and manufacturing medicinal products for disease prevention, detection, healing, and relief for humans (and animals).

Unfortunately, statistics show that most Bio-Med startups fail within their first year or two in business.  These failures can be attributed to a variety of different factors. Based on my 20 years of experience with hundreds of Bio-Med companies, in most cases, companies employed the wrong team members and spent specious time and money on them, which could have been invested better.

When it comes to the Bio-Med industry, a few things are more important than choosing the right business partner to suit your own specific needs.

 

What should you ask yourself before hiring pharmaceutical consulting services?

There are many consultants in the BioMed industry, so choosing the right one for your needs to be done thoughtfully and cautiously.

Here are some expert questions you should ask when considering different options that will assist you in carefully choosing the right consulting services:

  • Does your consultant have the right experience?
  • Has your consultant worked with many global and multinational clients?
  • Does your consultant have combined engineering, technological and regulatory capabilities?
  • Does your consultants’ track record include quality-related positions?
  • Does your consultant “see the whole picture” and are they experienced with the post-clinical and industrial stages?
  • Is your consultant multi-skilled, and can they support your specific needs every step of the way?
  • Does your consultant have a broad professional network that can benefit you?

 

The pharma industry’s most significant innovations and success stories started from small R&D companies relying on professional and reliable long-term consulting services and support.

Bio-pharma consultancy usually begins in the early drug development stages, before clinical trials, and after the safety and efficacy of all products are approved, and marketing approval is in place.

 

Pharmaceutical drug development consultancy

A successful pharmaceutical drug substance and product development process is a unique combination of innovation, quality, and regulatory compliance.

 

Pharmaceutical and BioTech products and services categories

The Bio-Pharmaceutical industry has developed significantly over the past two decades into some new areas alongside traditional ones, including:

  • Small molecules
  • Biologicals
  • Gene therapy
  • Cell therapy
  • Nano-robotics
  • Regenerative Medicine
  • Biological sensors & diagnostics
  • Optogenetic
  • Preventive medicine
  • Personalized medicine
  • Precise medicine

 

Indeed, technology is a significant factor, but as part of my pharmaceutical product development consultancy, I tend to integrate quality by design using GMP principles and other regulatory considerations alongside long-term thinking and consideration for the later stages of the project.

At the end of the day, all medicinal products need marketing approval from the FDA and the EMA or at least due diligence, and we need to set those foundational stepping stones early on in the development phase.

All my pharmaceutical consulting projects have involved innovative technology and were fully compliant with the various EMA and FDA regulations.

 

Pharmaceutical strategy consultancy

In this day and age, the global pharmaceutical market is an eclectic mix of heterogeneous, innovative, dynamic, and fascinating. This sector demonstrates high growth rates and endless potential in the larger context of the global economy. The Covid-19 pandemic in 2020, did indeed give the pharmaceutical industry a boost that is becoming increasingly clear.

The global pharmaceutical industry offers various solutions and products for the good of humanity to improve the quality of life.

The global pharmaceutical industry is highly competitive, so the correct approach and strategy need to be in place to convert potential into a success story. Defining a clear strategy to find the best niche for your innovative medicinal product and implementing your tactic accordingly is mandatory.

I have consulted many skilled scientists and researchers from various fields of expertise, including biologics drugs, small molecules, cell therapy, gene therapy, precision medicine, and even herbal medicine, who bring brilliant and unique ideas to the budding pharmaceutical industry.

 

Strategic consulting milestones for pharma companies

Strategies for pharmaceutical companies need to be built based on well-defined methodologies. This includes landmarks such as:

  • Risk Analysis
  • Market analysis
  • Competitors
  • Clinical strategy
  • Regulatory strategy
  • Target market Local regulation and Insurance coverage policies

 

I always advise my clients to think creatively and find the best way to dominant a larger market share with less regulatory complexities.

 

Pharmaceutical regulatory consultancy

The regulatory requirements for pharmaceutical drugs are stringent compared to other industries.

As part of my pharmaceutical consultancy, I’m working closely with my clients, primarily concerning the safety and effectiveness aspects of the NDA and CMC file before submission to the FDA and other related regulatory bodies.

 

Pharmaceutical pre-submission consulting outcomes

It goes without saying that numerous tests need to be carried out on investigational medicinal products before they can be approved, regulated, and brought to market.

Here are some important milestones for consideration:

  • In-vitro studies
  • Pre-clinical study protocols and reports
  • GLP
  • PK & PD
  • Risk assessment
  • GMP
  • Validation
  • Clinical batches manufacturing
  • Clinical trials protocols and reports
  • Drug product label
  • NDA file
  • Manufacturing process technology
  • Scale-up
  • Contract manufacturing

 

Usually, there is no second chance when it comes to gaining approval from the various global regulatory bodies, so it’s vital to get things right the first time around.

My recommendation is that you employ consultants with a holistic approach, have multi-areas of expertise, as well as broad and robust experience to assist you from ‘concept to sale.’

 

Pharmaceutical quality and GxP consultancy

To bring a safe and effective product to market, you need to be aligned with industry-standard regulatory requirements and good practices.

In parallel to the pharmaceutical product development phase, you need professional quality and GxP consulting to establish your company’s quality management system to ensure it is set up right for the short and long term.

Firstly, you need to define, together with your pharmaceutical GMP consultant, what kind of quality management system will support your business goals best.

 

What type of Quality System will serve you best?

The quality management system you should adopt in your company depends on several factors, including:

Factor Examples
Drug product type
  • Solid/semi-solid/liquid dosage form
  • Semi-solid dosage form
  • Liquid dosage form
  • Gaseous dosage form
  • Injectables/topical/oral
Clinical stage
  • Pre-clinical
  • Clinical- phase I
  • Clinical- phase II
  • Clinical- phase III
  • Clinical- phase VI
Outsourced manufacturing capabilities
  • Certification from health authorities
  • Last audits observations
  • Contract manufacturing organization clean rooms
  • Contract manufacturing organization’s Quality Management system
  • Qualification & Validation
  • Experience in the bio-pharma industry
Risk level
  • High risk
  • Mid risk
  • Minor risk
  • No risk
Target markets
  • US
  • Eu
  • Canada
  • Japan
  • Australia
  • UK
  • Rest of the world
Regulatory requirements
  • CFR
  • Eudralex
  • PICS
  • WHO
  • GMP
Territory/local regulations Based on the specific territory
Potential business partners and clients
  • Big pharma
  • VCs
  • Governmental bodies
  • Academy
Potential end-users
  • Physicians
  • Clinics
  • Pharmacies
  • Home use

 

Global regulations, including those set and stipulated by the FDA, EMA, WHO, TGA, and others, require an effective quality management system to ensure that medicinal products are used by humans as part of the clinical trials and for commercial use are safe and effective.

 

What are the main pillars of a Quality Management System?

A Quality Management System is a methodology that needs to be implemented and assimilated into an organization correctly. The main quality management system pillars are detailed below:

  • Risk-based approach
  • Criticality
  • Control
  • Documentation
  • Consistency
  • Data integrity
  • Continuous improvement

 

As part of the pharmaceutical quality consulting phase, I analyze any gaps in quality, establish an SOP template for you and write all your policies and procedures tailored to your company’s needs, from product characteristics to the development phase and business goals and beyond.

After documents have been approved, I will train all relevant employees, and we will begin to assimilate the procedures into your company’s day-to-day activities or enterprise.

As part of the pharma quality consulting process, I always tell my clients that all activities in the company have to be correctly and specifically defined and documented accordingly.

At the conclusion of the pharmaceutical quality consulting phase, I will conduct a mock audit ahead of the third-party external audit in order to maximize the chances of having the quality certification as soon as possible.

 

Pharmaceutical facility design consultancy

To develop your pharmaceutical drug substance and drug product, you need an appropriate facility. Whether it’s a laboratory or a cleanroom manufacturing facility, it has to be adequately designed.

Besides pharmaceutical facility design consulting to ensure the new facility fits your needs, it must comply with the relevant regulatory requirements. For instance, laboratories in the pharmaceutical industry may be designed to comply with the ISO 17025, GLP, and GMP regulations, while pharmaceutical manufacturing facilities will comply with the numerous GMP standards.

 

Pharmaceutical facility design consulting steps

Laboratory and pharmaceutical manufacturing facilities and cleanrooms should meet strict regulatory requirements and good practices. The facility cannot have the right to operate unless it was audited by the relevant health authorities and was approved.

The facility design project will include the following steps:

  • Conceptual design
  • User requirements
  • Clean rooms classification
  • Equipment and personnel flow
  • Program and specifications
  • Basis of Design document
  • Utilities & equipment
  • Budget estimation
  • Contracts & agreements

 

Pharmaceutical GxP lead auditor

What type of auditor services are right for you?

Second and third-party audits are a common practice in the BioMed industry.

On the one hand, you will need to be audited by regulatory agencies and business partners, while on the other, you need to audit your partners, service providers, and suppliers.

Here are some audit types that should be performed:

  • Raw materials suppliers’ audits
  • Laboratory audits
  • Service providers’ audits
  • Equipment manufacturers’ audits
  • Contract manufacturers’ audits

 

To ensure you choose the best partners along the way to meet your requirements, you need auditing capabilities, professional consultancy, and proper guidance.

Moreover, the GMP regulations require you to qualify and approve your suppliers before authorizing them.

I’m a certified lead auditor, recognized and accredited by the global NSF, IRCA, and CQI, with a proven track record of many first and second-party audits worldwide.

I offer my clients my lead auditor capabilities as required.

 

Pharmaceutical consulting Summary

The journey of a new investigational pharmaceutical product, from the development phase and until a safe, effective, and compliant end product in line with regulations has been produced and has received marketing approval, is a long one. It requires patience, sufficient budget, multidisciplinary skills, in-house professionalism, and professional consulting.

You have two options before you achieve your goals. One is to possess all the relevant skills, knowledge, and practical experience yourself; the second is to use pharmaceutical consulting experts with the right know-how and expertise.

To reach your goals effectively, you will need pharmaceutical consulting services at several points in the process. Hiring the right pharmaceutical and BioMed consultant will surely save you precious time and money every step of the way.

A highly experienced consultant will add value from start to finish, especially if they possess the relevant regulatory requirements know-how and have consulted for hundreds of different pharmaceutical clients over the years.

I have 20 years of experience in pharmaceutical consulting and supporting novel medicinal product development and startups. I proudly assist them along their journey, all the way through to gaining regulatory marketing approval.

I invite you to contact me today for a full consultation. It will be my pleasure to meet you.

Contact me today
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