In an era of established pharmaceutical regulation from various corners of the industry, can medical businesses deal with the challenges of getting drugs approved and to the market without pharmaceutical regulatory consulting services? They don't generally do it on their own; pharmaceutical regulatory consultants assist in navigating obstacles and generally shepherd companies toward drug marketing and approval solutions.

For getting some of the low-down about how pharmaceutical regulatory consultants work with companies in today's market, the web can present some interesting and relevant opportunities. Readers interested in taking on a partnership with pharmaceutical regulatory consulting firms can find:

1. Medical trade journal and association resources covering aspects of the relationship between medical companies and pharmaceutical regulatory consultants.

2. More from business archive sites that elaborate on challenges met by regulatory affairs consulting companies and others in related work.

3. Blog-style resources for further defining the goals and challenges of pharmaceutical regulatory consultants.

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Look to journals and association sites for finding out about pharmaceutical regulatory consultants

One way to find out how consulting companies are assisting with regulatory challenges is through the network of medical business journals, periodicals and trade association resources available on the web.

I recommend: Find timely articles on how regulation gets done in the pharmaceutical regulatory consulting industry at Medical News Today. For more resources from an organization tailored to pharmaceutical regulatory consulting knowledge, try the site of the American Society of Consultant Pharmacists.

Get more on the challenges pharmaceutical regulatory consultants face from business news aggregates

Some prominent business article sites will also cover aspects that pharmaceutical regulatory consultant shops deal with, including FDA approvals, regulations and changes, as well as other practical considerations. Seeing news about these factors can help a business anticipate what kinds of services a consulting shop will provide, and asking intelligent questions will get these customers closer to their goals for getting drugs out to the market.

I recommend: Posts on the Business Exchange site break down FDA regulatory consulting services news related to pharmaceutical regulatory consulting and food regulations. Find out much more with archives articles at sites like Goliath: "Business Knowledge on Demand."

Find more on pharmaceutical regulatory consultants from public web pages

More list-type sites offer directory-style resources for readers to further explore the difference between various pharmaceutical regulatory consulting shops and how they do business. Browse these sites to get a picture of how firms are competing to offer these kinds of consulting services to businesses looking to score with new drugs or get products renovated for approval.

I recommend: For a collection of blog resources related to Drug Approvals and Regulation, see the WordPress page where these are gathered for readers. For a directory of pharmaceutical regulatory consultants, try Dmoz, an open directory site for finding pharmaceutical regulatory consulting shops online.

Pharmaceutical regulatory consulting firms help businesses establish and implement operational systems that assure compliance with regulatory initiatives. Using their vast resources, regulatory affairs consulting companies develop systems that focus on quality management, quality assurance and design control. Clinical and regulatory affairs consulting agencies help clients comprehend and comply with complex FDA and regulatory agency requirements.

Before beginning your search for FDA regulatory consulting services, it is important to define your consulting needs. Clearly identify the goal of your consultancy, including project scope, services needed, time frame and budget. This information will help you select the best pharmaceutical regulatory consultant to meet your specific needs.

When selecting a pharmaceutical regulatory consulting firm, research each consulting practice and evaluate the following:

1. How much experience does each regulatory affairs consulting agency have in developing regulatory compliance solutions for your business sector?

2. What pharmaceutical regulatory consulting services do the agencies offer to improve operational productivity and quality assurance?

3. How much should your business invest in a customized pharmaceutical regulatory consulting service?

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Hire pharmaceutical regulatory consultants who specialize in your market

Select pharmaceutical regulatory training consultants who are seasoned professionals with extensive experience in your business sector. Ask to see a list of past and present clients, and request references.

I recommend: Campbell Alliance provides regulatory consulting services to the pharmaceutical and biotech industries and features an extensive online client list. Ehrreich Consulting has experience with a wide range of clients across the globe from small startup companies to major firms, including biologics, pharmaceutical, biotech, device and diagnostics companies. Quality and Compliance Consulting serves the pharmaceutical, medical device and biotechnology industries.

Choose pharmaceutical regulatory consulting firms with proven skills

Review the services offered by each regulatory affairs consulting company. Evaluate each firm's experience, qualifications and certifications, and request successful project examples similar in scope to your projected regulatory affairs services.

I recommend: STAT-A-MATRIX provides on-site audits, documentation review, training, coaching and facilitation focused on design controls, risk management, new product introduction, validation and process efficiencies. Octagon Research Solutions offers regulatory submission expertise, ensuring that documents are compliant based on electronic submission regulations and specifications. Pharmalink Consulting offers regulatory affairs and compliance services from development to market.

Select pharmaceutical regulatory consulting services that meet your budget

Many regulatory affairs consulting companies utilize an hourly project-based fee structure for short-term projects, while others operate on a retainer with special hourly rates for long-term clients. Your regulatory consultant cost will depend upon the scope of your services.

I recommend: Get a customized quote for regulatory affairs consulting services at Pharma Growth Strategies. Request a free compliance software demo or pricing information at MyComplianceOffice.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Make sure that it is written into your contract that the pharmaceutical regulatory consulting firm will not provide services to any direct product or business competitors during the course of your professional relationship.

Pharmaceutical regulatory consultants assist drug manufacturers and biotech companies with activities related to the submission of new drugs to the Food and Drug Administration (FDA). Responsibilities of regulatory consultants include ensuring manufactures and companies adhere to FDA regulations, reviewing clinical studies, reports and documentation, coordinating communications with the FDA and other health authorities with product submissions and advising on product labeling.

To have a career working as a pharmaceutical regulatory consultant, one must:

1. Possess a life sciences degree such as biology and biochemistry.

2. Complete Pharmaceutical and Biotech Training.

3. Be familiar with FDA regulations, particularly 21 CFR Part 11.

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Earn a life sciences degree to qualify for a career in clinical and regulatory affairs consulting

Individuals working for a clinical and regulatory affairs consulting company typically have a degree in life sciences, such as biology, biochemistry or botany, as well as knowledge of the drug development processes, Food and Drug Administration (FDA) regulations and current issues in the pharmaceutical industry. Pharmaceutical regulatory consulting services include providing guidance on the regulatory process for FDA submissions and training of staff.

I recommend: The University of Iowa offers a degree program in biology while the Colorado State University offers degrees in Biochemistry and Molecular Biology that will serve as a foundation for a career as a regulatory consultant.

Look for training courses for your pharmaceutical regulatory consulting education and training

Pharmaceutical regulatory consulting firms work to ensure drug manufactures are abiding by regulations and producing products that are safe and contain the ingredients (in the dosage amount) identified on packaging. Training to keep pharmaceutical regulatory consultants current in the field includes courses in Adverse Drug Events - Reporting and Regulatory Requirements, BioManufacturing of Protein Therapeutics: Rewards and Challenges, and Chemistry and Manufacturing & Controls (CMC) Regulatory Compliance for Biopharmaceuticals and Biologics. Pharmaceutical regulatory training also involves staying abreast of pharmaceutical regulatory compliances and pharmaceutical validation processes, such as Calibration in the FDA Regulated Industry, Pharmaceutical Quality Assurance and Control and U.S. FDA Regulatory compliance.

I recommend: The Center for Professional Innovation and Education and the Center for Professional Advancement offer Pharmaceutical Regulatory Compliance and Pharmaceutical & Biotech Training Courses.

Familiarize yourself with FDA regulations to train for pharmaceutical regulatory consulting

Individuals working for pharmaceutical and FDA regulatory consulting services must be knowledgeable with 21 CFR, particularly Part 11, which addresses the standards of electronic records and signatures. Like other industries, the pharmaceutical field is constantly evolving, requiring revisions to existing regulations or the legislation of new regulations. Pharmaceutical regulatory consultants must be up to date on topics such as the drug approval process and quality system compliance.

I recommend: FDA Regulatory markets books addressing FDA regulations and 21 CFR Part 11 Section 820.25 that refers to training requirements. Lab Compliance offers an online tutorial of 21 CFR Part 11 focusing on Electronic Records and Electronic Signatures.

Pharmaceutical regulatory consultants ensure that regulations and standards of quality are met in medical device and medication dispensing. They also monitor and regulate drug trials and trial data report submissions. Pharmaceutical consultants enforce regulations of quality, sanitation, and proper procedure in all areas of pharmaceutical trials, research and practice.

It's important to understand key terms associated with pharmaceutical regulatory consulting to ascertain if working with a pharmaceutical regulatory consultant will benefit your business, or if a job in the consultancy field is right for you.

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New Drug Submissions

A New Drug Submission, or NDS, is an application that must be filed with the FDA when a generic form of a drug is introduced to the pharmaceutical market. The NDS must prove that the generic drug form is as potent and effective as the brand name equivalent.

I recommend: Science Careers Magazine explains the process of filing an NDS claim and the role that pharmaceutical regulatory consultants play in the filing.

FDA Review Division

The FDA Review Division is a division of the FDA that reviews and inspects new drugs before they are released onto the market to ensure their effectiveness and safety, and to identify any potential side effects. Pharmaceutical regulatory consultants often work with FDA agents in this process.

I recommend: The FDA explains the process for drug review and new drug investigation, and how the process is key in pharmaceutical regulation.

Regulatory Affairs Professional Society

The Regulatory Affairs Professional Society (RAPS) is a professional organization of pharmaceutical regulatory consultants and service providers. RAPS provides educational and support resources as well as news and drug trial regulation information for members.

I recommend: RAPS explains the educational and professional resources it provides to pharmaceutical regulatory consultant members.

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) refers to a regulatory guideline implemented by the US Food and Drug Administration in the laboratory testing and manufacturing of pharmaceuticals. Pharmaceutical regulatory consultants are familiar with GMP and can provide assistance with achieving compliance.

I recommend: GMP 1st explains GMP and how this federal guideline helps to ensure quality in pharmaceutical services and manufacturing.

Medical device services

Medical device services is the testing of medical and laboratory devices used in drug and clinic trials to ensure the devices are in proper working order and sanitized properly. Regulatory consultants often offer this service.

I recommend: Intertek explains medical device services that their international company offers to pharmaceutical businesses and how these services ensure quality laboratory testing and device operation.

Medical Dictionary for Regulatory Activities (MedDRA)

Medical Dictionary for Regulatory Activities (MedDRA) is a continuously updated and internationally recognized terminology list focusing on regulatory practice in the medical and pharmaceutical industries.

I recommend: MedDRA's website explains its function and how it benefits regulatory consultants, physicians and other medical professionals.