Pharmaceutical consulting is an extremely varied industry, encompassing consultants working across numerous roles. To become a pharmaceutical consultant, one will typically require at least 5-7 years of experience and an appropriate degree in pharmacology or health services.
Pharmaceutical business consultants must have the ability to quickly recognize issues and communicate them clearly, as well as staying current with developments within the industry.
Regulatory Affairs
Regulatory Affairs Specialists assist medical device and pharmaceutical companies to stay abreast of ever-evolving global health authorities' requirements. They review product promotional materials or internal documentation to ascertain compliance with regulations; additionally they advise project teams of any issues that might impede regulatory submissions, export, labeling compliance.
When selecting a regulatory consultant, take into account their experience within your therapeutic area of concern. It's advisable to select someone familiar with similar drugs if your therapy requires complex regulations.
An effective Regulatory Affairs Consulting Partner should act as an extension of your team, adaptable, organized and equipped with vast regulatory knowledge that enables it to drive product forward through regulatory pathways. From NDA, BLA, IDE or PMA filings for new drugs through CESP ANDA AND NDA submissions for generic medicines; our regulatory experts specialize in compiling dossiers published as eCTD formats using software before filing them with regulatory agencies.
Product Development
Pharmaceutical consulting firm can assist with creating customized formulations of drugs. They can oversee all aspects of in-house formulation and product licensing activities, from liquid orals (true solutions, suspensions and syrups) through to tablets such as analgesics and laxatives for pain management as well as suppositories and other dosage forms that meet specialized dosage specifications.
Pharmaceutical consultants require exceptional critical thinking skills and scientific knowledge of drug production processes in order to establish company policies which ensure drug production follows safety rules and government regulations.
Pharmaceutical consultants offer expert and objective data-driven research. Their experience can ensure your drug's market success by helping expand into new markets or uncover hidden opportunities; additionally they can rewrite reimbursement policies, optimize clinical positioning and enhance supply chain management - potentially saving a great deal of money in the process.
Quality Assurance
Businesses offering FDA-cleared products or processes should employ an efficient quality assurance team, since failure to do so could result in unhappy customers, 483 notices from the FDA or possible litigation. Consulting firms specializing in pharmaceutical quality assurance may offer invaluable expertise that helps prevent issues that lead to regulatory compliance problems.
Crooker (Parexel): When selecting a consultant, the first step should be checking references and case studies on their website. Check for evidence of success and engagement within your industry as well as membership with ISPE, PDA or FDLI trade associations.
Pharmaceutical quality assurance requires confidence and excellent communication skills as part of its career requirements. If you possess both technical and interpersonal abilities, pharmaceutical quality assurance can be extremely rewarding; you'll quickly expand your knowledge of the industry while taking on challenges associated with working in various environments.
Manufacturing
No matter whether they're planning on releasing their inaugural drug or just want an outside perspective before doing it themselves, pharmaceutical companies need an experienced consultant in order to establish policies and procedures in line with federal regulations about manufacturing drugs - from insurance plans and distribution strategies, all the way down to policy recommendations.
Consulting firms' responsibility also extends to helping pharma and biotech clients navigate the process of selecting Contract Development and Manufacturing Organizations (CDMO) to handle various stages of drug production, from contract negotiations and cost control measures through delivery timelines to making sure these organizations comply with current Good Manufacturing Practice requirements (cGMP).
An effective consultant team can drastically shorten your time to market, help establish long-term GxP standards, and equip you for an effortless commercialization journey. Download our 2023 drug development supply chain whitepaper to gain more insights - it includes detailed supplier and product offerings alongside contact details so that you can make informed purchasing decisions.
