Pharma Regulatory

Regulatory excellence, delivered:

Timely and compliant submissions to EMA and EU member-state authorities

Regulatory Matters

Expert Regulatory Guidance for Human Medicines: From MAA to Lifecycle Management

Streamline your regulatory journey with our comprehensive consulting services,
ensuring successful marketing authorization and ongoing compliance for human medicines.

In the complex and ever-evolving landscape of human medicine regulations, navigating the path to marketing authorization and maintaining compliance can be daunting. Our regulatory consulting firm provides expert guidance and support to pharmaceutical companies, helping you bring innovative treatments to patients faster and more efficiently.

Our Expertise

Marketing Authorization Application (MAA) Registration: Our team of seasoned regulatory professionals will guide you through the entire MAA submission process, ensuring your application meets the European Medicines Agency's (EMA) requirements and expectations.
Lifecycle Management of Approved Marketing Authorizations (MA): We'll help you maintain compliance and optimize your approved MA, including variations, renewals, and post-authorization safety studies (PASS).

Benefits of Partnering With Us

Accelerated Time-to-Market: Our expertise ensures timely and successful MAA submissions, getting your innovative treatments to patients faster.
Regulatory Compliance: We'll help you navigate the complex regulatory landscape, minimizing the risk of non-compliance and ensuring ongoing market access.
Cost Savings: Our efficient regulatory strategies and processes reduce the financial burden of regulatory compliance.
Expert Guidance: Our team of regulatory experts provides personalized support and guidance throughout the entire regulatory journey.

Why Choose Our Regulatory Consulting Firm

Proven Track Record: Our team has a successful history of MAA submissions and lifecycle management for human medicines.
In-Depth Knowledge: We stay up-to-date with the latest regulatory requirements, guidelines, and best practices, ensuring our clients receive the most effective guidance.
Personalized Service: We tailor our services to meet the unique needs of each client, providing a dedicated point of contact and flexible support.

Get in Touch

Ready to streamline your regulatory journey and bring your innovative human medicines to market faster?
Contact us today to learn more about our consulting services and how we can support your regulatory needs.

List of Human Medicine Experience

#abacavir_lamivudine #acebutolol #acenocoumarol #acetylcysteine #acetylsalicylacid #aciclovir #acitretin_neotigason #agomelatine #alendronineacid #alendronineacid_cholecalciferol #alfacalcidol #alfuzosine #allopurinol #alprazolam #amiloride #amiloride_hydrochloorthiazide #amiodaron_hcl #amisulpride #amitriptyline #amlodipine #amlodipine_valsartan #amoxicilline #amoxicillineClavulaanacid #antagel #apc #apixaban #aprepitant #aripiprazol #arseentrioxide #ascorbineacid_vitamine_c #atazanavir #atenolol #atenolol-chloortalidon #atomoxetine #atorvastatine #azacitidine #azathioprine #azitromycine #baclofen #betahistine #bezafibraat #bicalutamide #bisacodyl #bisoprolol #bortezomib #bosentan #brinzolamide #broomhexine HCl #budesonide #bumetanide #bupivacaine #buprenorfine_naloxon #buspiron #Busulfan #Cabazitaxel #cabergoline #calciumcarbonaat #candesartan #candesartan_hct #capecitabine #captopril-hct #carbamazepin #carvedilol #celecoxib #cetirizine #chloortalidon #ciclosporine #cinacalcet #cinnarizine #ciprofloxacine #citalopram #claritromycine #clobazam #clopidogrel #clozapine #colchicine #dapagliflozine #darunavir #decubal #deferasirox #desloratadine #desogestrel #desogestrel_ethinylestradiol #dexpantenol #diazepam #diclofenackalium #diclofenacnatrium #diltiazem #dimethylfumaraat #diphantoine #diphantoine-z #disulfiram #docetaxel #domperidon #dorzolamide #dorzolamide_timolol #doxazosine #doxorubicine #doxycycline #drospirenon_ethinylestradiol #duloxetine #dutasteride #dutasteride_tamsulosine #efavirenz #efavirenz_emtricitabine_tenofovir #eletriptan #emla #emtricitabine_tenofovir #enalapril #entecavir #eplerenon #escitalopram #esomeprazol #ethymal #etoricoxib #ezetimibe #ezetimibe-simvastatine #famotidine #fampridine #febuxostat #felodipine #fentanyl #ferrofumaraat #fexofenadine #finasteride #fingolimod #flecainide #floxapen #flucloxacilline #fluconazol #flunitrazepam #fluoxetine #flurazepam #fluticason #fluvastatine #fluvoxamine #foliumacid #fosfomycine #fosinopril #fosinoprilnatrium_hydrochloorthiazide #fulvestrant #furosemide #gabapentine #galantamine #gefitinib #gemcitabine #gemfibrozil #gestodeen_ethinylestradiol #gliclazide #glimepiride #granisetron #huisstijl #hydrochloorthiazide #hydroxycarbamide #hydroxychloroquine #ibandronineacid #ibuprofen #ibuprofen-lysine #indapamide #indometacine #ipratropiumbromide #irbesartan #irbesartan_hydrochloorthiazide #irinotecan #isosorbidedinitraat #isosorbidemononitraat #isotretinoine #itraconazol #ivabradine #ketoconazol #ketotifen #lacosamide #lactulose #lamivudine #lamivudine_zidovudine #lamotrigine #lansoprazol #latanoprost #latanoprost_timolol #leflunomide #lenalidomide #lercanidipine #levetiracetam #levocetirizine #levofloxacine #levonorgestrel #levonorgestrel-ethinylestradiol #lisinopril #lisinopril_hydrochloorthiazide #loperamide #loratadine #lorazepam #lormetazepam #losartankalium #losartankalium_hydrochloorthiazide #macrogol #mebendazol #mebeverine #melfalan #meloxicam #memantine #mesalazine #metformine #methadon #methotrexate #metoprolol #metronidazol #miconazol #miconazol_hydrocortison #midazolam #minocycline #mirtazapine #modafinil #mometason #montelukast #morfinesulfaat #moxifloxacine #mycofenolaat #na-valproaat #naproxen #natriumchloride #nebivolol #nevirapine #nicotine #nifedipine #nintedanib #nitrazepam #nitrofurantoïne #norfloxacine #nortriptyline #noscapine_hcl #octreotide #olanzapine #olmesartanmedoxomil #olmesartanmedoxomil_amlodipine #olmesartanmedoxomil_hydrochloorthiazide #omeprazol #ors #oseltamivir #oxazepam #oxybutynine #oxycodon #paclitaxel #pamidronaat #pantoprazol #paracetamol #paracetamol_coffeine #paroxetine #perindopril #perindopril-amlodipine #pioglitazon #piperacilline-tazobactam #pirfenidone #Pomalidomide #posaconazol #pramipexol #pravastatine #prednisolon #prednison #pregabaline #propranolol #propylthiouracil #psyllium #quetiapine #rabeprazol #raloxifeen #ramipril #ramipril_hydrochloorthiazide #rapilysin #rasagiline #remifentanil #repaglinide #reteplase_rapilysin #risedronaat #risedronaat calcium #risperidon #rivaroxaban #rivastigmine #rizatriptan #ropinirol #rosuvastatine #Sapropterine #sertraline #sevelameer #sigilamyl #sildenafil #silodosine #simvastatine #sitagliptine #solifenacine #solifenacinesuccinaat_tamsulosine #sotalol #musclebalm #spironolacton #stesolid #sucralfaat #sumatriptan #sunitinib #tadalafil #tamoxifen #tamsulosin #teicoplanine #telmisartan #telmisartan_hydrochloorthiazide #temazepam #temozolomide #tenofovirdisoproxil #terbinafine #teriflunomide #thymesyrup #ticagrelor #timolol #tirofiban #tolbutamide #tolterodine #topiramaat #topotecan #tramadol #tramadol_paracetamol #tranylcypromine #trazodon_hcl #triamcinolon #triamtereen #valaciclovir #valeriaan_fs #valganciclovir #valsartan #vancomycine #varenicline #venlafaxine #verapamil #vitamine_d_fs #wrattentinctuur_md #xylometazoline #zilversulfadiazine #zoledronineacid #zolmitriptan #zolpidem #zopiclon #saltsolution

Page updated

Google Sites

Report abuse